← Product Code [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK) · K960972 # DISPOSABLE GAS SAMPLING INTERFACE KITS (K960972) _Marquest Medical Products, Inc. · CCK · Oct 18, 1996 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K960972 ## Device Facts - **Applicant:** Marquest Medical Products, Inc. - **Product Code:** [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK.md) - **Decision Date:** Oct 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1400 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Intended Use Indicated use - When a sample of a patient's expired gas is to be analyzed. Targeted population - Any patient requiring monitoring of expired gases. Environment of use - Hospital, anesthesia, ICU, PACU, respiratory therapy ## Device Story Small-bore tubing with luer fittings; facilitates transport of patient expired gas samples to external gas analyzers. Used in hospital environments (anesthesia, ICU, PACU, respiratory therapy) by clinicians. Device features various lengths, diameters, and optional in-line filters. Single-use disposable design. ## Clinical Evidence Bench testing only; performance testing of luer fittings confirms equivalence to predicate. ## Technological Characteristics Small-bore tubing with luer fittings; materials include PVC, PC, ABS, Acrylic, and PE. Optional in-line filter. Single-use, disposable. ## Regulatory Identification A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry. ## Predicate Devices - Gibeck, Inc. disposable gas sampling lines ([K841722](/device/K841722.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} The New Marq of Excellence K900972 OCT 18 1996 Marquest Medical Products, Inc. 11039 East Lansing Circle Englewood, Colorado 80112 U.S.A. 303 790 4835 phone 303 799 0210 fax Non-Confidential Summary of Safety and Effectiveness March 1, 1996 page 1 of 2 Marquest Medical Products, Inc. 11039 East Lansing Circle Englewood, CO 80112 Tel - (303) 790-4835 Fax - (303) 799-0210 Official contact: Tom Dielmann, Director, Regulatory Affairs / Quality Assurance Proprietary or Trade Name: Gas Sampling Interface Kits Common/Usual Name: Disposable Gas Sampling Lines Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase Intended device: Gas Sampling Interface Kits Predicate devices: Gibeck, Inc. - disposable gas sampling lines - K841722 Device description: The intended product is a small bore tube with luer fittings which permit a sample of patient's expired gas to be delivered to an analyzer. The device may be of various lengths, tubing diameters and have an in-line filter. Intended use: Indicated use - When a sample of a patient's expired gas is to be analyzed. Targeted population - Any patient requiring monitoring of expired gases. Environment of use - Hospital, anesthesia, ICU, PACU, respiratory therapy Comparison to predicate devices: | Attribute | Marquest | Dryden (Gibeck) | | --- | --- | --- | | Use | | | | Indicated for use with expired gas sampling monitors | Yes | Yes | page 3 of 21 {1} Non-Confidential Summary of Safety and Effectiveness (continued) March 1, 1996 page 2 of 2 Comparison to predicate devices: (continued) | Attribute | Marquest | Dryden (Gibeck) | | --- | --- | --- | | Use (continued) | | | | Intended for use in anesthesia | Yes | Yes | | Intended for use in respiratory therapy | Yes | Yes | | Indicated for single use | Yes | Yes | | Design | | | | Luer fittings | Yes | Yes | | Clear | Yes | Yes | | Various diameters of tubing | Yes | Yes | | Various lengths of tubing | Yes | Yes | | Maybe supplied with filter | Yes | Yes | | Materials | | | | Luers made of PVC, PC, ABS, Acrylic | Yes | Yes | | Tubing - PVC, PE, PVC/PE | Yes | Yes | | Performance Testing | | | | Luer fittings | Yes | Yes | ## B. Differences Any differences that do exist would not have a significant effect on the safety or effectiveness of the device. page 4 of 21 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K960972](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K960972) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com