Part 868 Subpart F—Therapeutic Devices
FDA submissions for Part 868 Subpart F—Therapeutic Devices in the Anesthesiology (AN) review panel, including product codes and regulations.
Section range: §§ 868.5090–868.5995
CFR Part: 868
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| BWC | Needle, Emergency Airway | 868.5090 | 2 | 14 |
| QCX | Retrograde Intubation Set | 868.5095 | 2 | 1 |
| BTQ | Airway, Nasopharyngeal | 868.5100 | 1 | 19 |
| PMB | External Airway | 868.5105 | 2 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 868.5110 | 1 | 57 |
| PHS | Oral Airway Assist | 868.5110 | 1 | 0 |
| MZT | Device, Heimlich Maneuver Assist | 868.5115 | 2 | 1 |
| BSO | Catheter, Conduction, Anesthetic | 868.5120 | 2 | 75 |
| MAJ | Catheter, Percutaneous, Intraspinal, Short Term | 868.5120 | 2 | 6 |
| OFQ | Anesthesia Kit | 868.5120 | 2 | 0 |
| OFT | Spinal Epidural Anesthesia Kit | 868.5120 | 2 | 0 |
| OFU | Spinal Anesthesia Kit | 868.5120 | 2 | 0 |
| OFV | Regional Anesthesia Kit | 868.5120 | 2 | 0 |
| OGD | Custom Anesthesia Tray | 868.5120 | 2 | 0 |
| OGE | Epidural Anesthesia Kit | 868.5120 | 2 | 0 |
| OGF | Glossopharyngeal Anesthesia Kit | 868.5120 | 2 | 0 |
| BSN | Filter, Conduction, Anesthetic | 868.5130 | 2 | 9 |
| CAZ | Anesthesia Conduction Kit | 868.5140 | 2 | 155 |
| OGA | Brachial Plexus Anesthesia Kit | 868.5140 | 2 | 0 |
| OGB | Caudal Anesthesia Kit | 868.5140 | 2 | 0 |
| OGJ | Nerve Block Tray | 868.5140 | 2 | 0 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 868.5150 | 2 | 152 |
| MIA | Needle, Spinal, Short Term | 868.5150 | 2 | 10 |
| NMR | Needle, Spinal, Short Term, Reprocessed | 868.5150 | 2 | 0 |
| NNH | Needle, Conduction, Anesthesia, Reprocessed | 868.5150 | 2 | 0 |
| OGC | Continuous Brachial Plexus Block Tray | 868.5150 | 2 | 0 |
| BSZ | Gas-Machine, Anesthesia | 868.5160 | 2 | 187 |
| MRN | Apparatus, Nitric Oxide Delivery | 868.5165 | 2 | 33 |
| MRO | Apparatus, Nitric Oxide, Backup Delivery | 868.5165 | 2 | 4 |
| CCT | Applicator (Laryngo-Tracheal), Topical Anesthesia | 868.5170 | 2 | 10 |
| CCO | Bed, Rocking, Breathing Assist | 868.5180 | 2 | 0 |
| BYO | Bottle, Blow | 868.5220 | 1 | 4 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 868.5240 | 1 | 184 |
| OFP | Anesthesia Breathing Circuit Kit (Adult & Pediatric) | 868.5240 | 1 | 0 |
| CAG | Circulator, Breathing-Circuit | 868.5250 | 2 | 0 |
| CAH | Filter, Bacterial, Breathing-Circuit | 868.5260 | 2 | 200 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 868.5270 | 2 | 45 |
| QBY | Positive Airway Pressure System | 868.5273 | 2 | 2 |
| JAY | Support, Breathing Tube | 868.5280 | 1 | 19 |
| CBL | Absorbent, Carbon-Dioxide | 868.5300 | 1 | 5 |
| BSF | Absorber, Carbon-Dioxide | 868.5310 | 1 | 8 |
| BTC | Bag, Reservoir | 868.5320 | 1 | 19 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 868.5330 | 2 | 55 |
| CAT | Cannula, Nasal, Oxygen | 868.5340 | 1 | 42 |
| BZB | Catheter, Nasal, Oxygen | 868.5350 | 1 | 8 |
| BYN | Chair, Posture, For Cardiac And Pulmonary Treatment | 868.5365 | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 868.5375 | 1 | 73 |
| BWL | Apparatus, Electronanesthesia | 868.5400 | 3 | 0 |
| BTB | Hook, Ether | 868.5420 | 1 | 0 |
| BTP | Dropper, Ether | 868.5420 | 1 | 1 |
| CBN | Apparatus, Gas-Scavenging | 868.5430 | 2 | 43 |
| CAW | Generator, Oxygen, Portable | 868.5440 | 2 | 284 |
| OLF | Medevac Use Oxygen Generator | 868.5440 | 2 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 868.5450 | 2 | 221 |
| OBN | Humidifier, Respiratory, Mask (Direct Patient Interface) | 868.5450 | 2 | 1 |
| OGG | Humidifier Nebulizer Kit | 868.5450 | 2 | 0 |
| QAV | High Flow/High Velocity Humidified Oxygen Delivery Device | 868.5454 | 2 | 3 |
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | 868.5460 | 1 | 20 |
| CBF | Chamber, Hyperbaric | 868.5470 | 2 | 69 |
| CAL | Laryngoscope, Non-Rigid | 868.5530 | 1 | 8 |
| CCW | Laryngoscope, Rigid | 868.5540 | 1 | 64 |
| OGH | Laryngoscope Kit | 868.5540 | 1 | 0 |
| BSJ | Mask, Gas, Anesthetic | 868.5550 | 1 | 51 |
| BTK | Strap, Head, Gas Mask | 868.5560 | 1 | 6 |
| KGB | Mask, Oxygen, Non-Rebreathing | 868.5570 | 1 | 13 |
| BYG | Mask, Oxygen | 868.5580 | 1 | 55 |
| KHA | Mask, Scavenging | 868.5590 | 1 | 1 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 868.5600 | 1 | 19 |
| BYP | Mouthpiece, Breathing | 868.5620 | 1 | 25 |
| CAF | Nebulizer (Direct Patient Interface) | 868.5630 | 2 | 507 |
| NVO | Spacer, Direct Patient Interface | 868.5630 | 2 | 2 |
| NVP | Holding Chambers, Direct Patient Interface | 868.5630 | 2 | 16 |
| SFP | Ventilator-Compatible Nebulizer | 868.5630 | 2 | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 868.5640 | 1 | 62 |
| CAO | Airway, Esophageal (Obturator) | 868.5650 | 2 | 6 |
| BYJ | Unit, Liquid-Oxygen, Portable | 868.5655 | 2 | 55 |
| OGL | Oxygen Administration Kit | 868.5655 | 2 | 0 |
| BYI | Percussor, Powered-Electric | 868.5665 | 2 | 57 |
| SDS | Compression-Based Airway Clearance Device | 868.5665 | 2 | 0 |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | 868.5665 | 2 | 3 |
| BYW | Device, Rebreathing | 868.5675 | 1 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 868.5690 | 2 | 108 |
| BYL | Tent, Oxygen | 868.5700 | 1 | 11 |
| FOG | Hood, Oxygen, Infant | 868.5700 | 1 | 9 |
| BYK | Tent, Oxygen, Electrically Powered | 868.5710 | 2 | 3 |
| FNC | Tent, Pediatric Aerosol | 868.5710 | 2 | 1 |
| BTS | Tube, Bronchial (W/Wo Connector) | 868.5720 | 2 | 6 |
| BTR | Tube, Tracheal (W/Wo Connector) | 868.5730 | 2 | 240 |
| LNZ | Changer, Tube, Endotracheal | 868.5730 | 2 | 2 |
| NMA | Tube, Tracheal, Reprocessed | 868.5730 | 2 | 0 |
| OQU | Airway Monitoring System | 868.5730 | 2 | 3 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 868.5740 | 2 | 34 |
| BSK | Cuff, Tracheal Tube, Inflatable | 868.5750 | 2 | 39 |
| CBG | Spreader, Cuff | 868.5760 | 1 | 1 |
| CBH | Device, Fixation, Tracheal Tube | 868.5770 | 1 | 47 |
| OGI | Nasal Endotracheal Tube Holder Kit | 868.5770 | 1 | 0 |
| BWB | Forceps, Tube Introduction | 868.5780 | 1 | 6 |
| BSR | Stylet, Tracheal Tube | 868.5790 | 1 | 32 |
| EPE | Brush, Cleaning, Tracheal Tube | 868.5795 | 1 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 868.5800 | 2 | 128 |
| JOH | Tube Tracheostomy And Tube Cuff | 868.5800 | 2 | 109 |
| NXA | Tracheotomy Care Kit | 868.5800 | 2 | 1 |
| OGP | Cricothyrotomy Kit | 868.5800 | 2 | 0 |
| OGV | Tracheostomy Cleaning Tray | 868.5800 | 2 | 0 |
| OGW | Tracheostomy Kit | 868.5800 | 2 | 0 |
| BZA | Connector, Airway (Extension) | 868.5810 | 1 | 94 |
| BRW | Protector, Dental | 868.5820 | 1 | 3 |
| CAC | Apparatus, Autotransfusion | 868.5830 | 2 | 195 |
| BYX | Tubing, Pressure And Accessories | 868.5860 | 1 | 62 |
| CBP | Valve, Non-Rebreathing | 868.5870 | 2 | 103 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 868.5880 | 2 | 57 |
| CBK | Ventilator, Continuous, Facility Use | 868.5895 | 2 | 504 |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 868.5895 | 2 | 47 |
| MNT | Sv70 Ventilator | 868.5895 | 2 | 25 |
| MOD | Accessory To Continuous Ventilator (Respirator) | 868.5895 | 2 | 13 |
| NOU | Continuous, Ventilator, Home Use | 868.5895 | 2 | 7 |
| NQY | Ventilator, Continuous, Minimal Ventilatory Support, Home Use | 868.5895 | 2 | 0 |
| ONZ | Mechanical Ventilator | 868.5895 | 2 | 6 |
| SGR | Noninvasive Positive Airway Pressure System, Facility Use | 868.5895 | 2 | 2 |
| BZD | Ventilator, Non-Continuous (Respirator) | 868.5905 | 2 | 456 |
| NFB | Conserver, Oxygen | 868.5905 | 2 | 71 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 868.5905 | 2 | 24 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 868.5905 | 2 | 10 |
| NMC | Mask, Ventilator, Non-Continuous, Reprocessed | 868.5905 | 2 | 0 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 868.5915 | 2 | 209 |
| OEV | Cardiopulmonary Resuscitation Aid Kit | 868.5915 | 2 | 0 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 868.5925 | 2 | 100 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 868.5935 | 2 | 21 |
| CBO | Attachment, Intermittent Mandatory Ventilation (Imv) | 868.5955 | 2 | 15 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 868.5965 | 2 | 80 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 868.5975 | 1 | 88 |
| BYH | Drain, Tee (Water Trap) | 868.5995 | 1 | 22 |
