← Product Code LRR · K964029 # EMERGENCY RELIEF KIT SYSTEM (K964029) _Baxter Healthcare Corp · LRR · Mar 17, 1997 · SU · SEKD_ **Canonical URL:** https://fda.innolitics.com/device/K964029 ## Device Facts - **Applicant:** Baxter Healthcare Corp - **Product Code:** LRR - **Decision Date:** Mar 17, 1997 - **Decision:** SEKD - **Submission Type:** Traditional - **Device Class:** Class N - **Review Panel:** SU - **Attributes:** Therapeutic ## Indications for Use The Baxter Emergency Relief™ System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance. ## Device Story Baxter Emergency Relief™ System is a collection of color-coded mini first aid kits containing various finished-good medical components. System serves as a centralized housing unit for first aid supplies. Used in emergency situations to provide basic treatment while awaiting professional medical assistance. Components include gauze dressings, eye pads, vinyl gloves, adhesive tape, scissors, sterile saline, metal extremity splints, cold packs, bandage strips, topical antiseptic ointment, and alcohol swabs. Device is intended for general use in emergency settings. ## Clinical Evidence No clinical data. Testing of the system was deemed not applicable as all regulated devices have an established regulatory path and are obtained in finished good form. ## Technological Characteristics System consists of a collection of pre-packaged, finished-good first aid components. No specific materials, energy sources, or software algorithms are utilized; the device is a kit of existing, regulated medical supplies. ## Regulatory Identification Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. ## Predicate Devices - Vinyl Gloves ([K952786](/device/K952786.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} MAR 04 '97 10:04AM QARA SURGICAL Baxter Surgical Group Baxter Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, Illinois 60085 USA P.5/7 708.473.1500 FAX: 708.785.2460 MAR 17 1997 K964089 # SUMMARY OF SAFETY AND EFFECTIVENESS ## Appendix E Manufacturer: Baxter Healthcare Corporation Surgical Group Thermal 808 Highway 24 West Moberly, Missouri 65270 Regulatory Affairs Contact: Maryalice Smith Surgical Group 1500 Waukegan Road Bldg. K McGaw Park, Illinois 60085 Telephone: (847) 785-3322 Date Summary Prepared: September 20, 1996 Product Trade Name: Baxter Emergency Relief™ Kit System Classification: Class I [21CFR not listed] Product Code 79LRR Predicate Device: Each component within the Emergency Relief System is a finished good with an established regulatory path when applicable. The devices which fall within this category include the following: 1. Gauze Dressing Class I Exempt 21CFR 878.4450 2. Oval Eye Pad Class I Exempt 21CFR 878.4440 3. Vinyl Gloves Class I 21CFR 880.6250 Baxter K952786 Bulk Non-Sterile 4. Adhesive Tape Class I Exempt 21CFR 880.5240 {1} MAR 04 '97 10:04AM QARA SURGICAL K964029 P.6/7 ## Predicate Device: | 5. | Scissors | Class I Exempt 21CFR 878.4800 | | --- | --- | --- | | 6. | Sterile Saline For Eye Irrigation | Over-The-Counter 21CFR 349.20 | | 7. | Metal Extremity Splint | Class I Exempt 21CFR 378.3910 | | 8. | Cold Pack | Preamendment Baxter Thermal | | 9. | Bandage Strips | Class I Exempt 21CFR 880.5240 | | 10. | Topical Antiseptic Ointment | Over-The-Counter 21CFR 333.110(a) | | 11. | Alcohol Swab | Over-The-Counter 21CFR 333 460(b)(2) Tenative Final Monograph for Health Care Antiseptic Drug Products; Proposed Rule. | ## Description: The Baxter Emergency Relief™ System is designed as one large unit which houses various first aid kits. Each mini kit contains various individual components traditionally used for first aid treatment. Each individual component is a finished good with an established regulatory path where applicable. All components are purchased as finished goods and packaged in the appropriate mini kit, including direction for use inserts. All direction for use inserts correspond to the instruction manual accompanying the system. ## Intended Use: The Baxter Emergency Relief™ System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance. 62 {2} MAR 04 '97 10:04AM QARA SURGICAL K964029 P.7/7 ## Substantial Equivalence: The Emergency Relief™ Kit System substantial equivalency is established by each device component contained within the mini kits in that: - intended use is the same ## Summary of Testing: Testing of the system was deemed not applicable as all regulated devices has an established regulatory path and is obtained in finished good form 63 --- **Source:** [https://fda.innolitics.com/device/K964029](https://fda.innolitics.com/device/K964029) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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