Bbl Gaspak Pouch

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K841307 ↗

FDA Product Code

FKJ

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

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  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the BBL GASPAK POUCH used for?

  The BBL GASPAK POUCH is designed for the cultivation of anaerobic microorganisms. It creates an oxygen-free environment necessary for the growth of anaerobic bacteria in laboratory settings.

• Is the BBL GASPAK POUCH reusable or single-use?

  The BBL GASPAK POUCH is supplied as a single-use device and should not be reused. This ensures sterility and prevents cross-contamination between different cultures.

• What are the storage requirements for the BBL GASPAK POUCH?

  The BBL GASPAK POUCH should be stored at room temperature. Proper storage conditions help maintain the integrity of the pouch and ensure it functions correctly when used for anaerobic culture.

• Is the BBL GASPAK POUCH MRI compatible?

  No, the BBL GASPAK POUCH is not MRI compatible. It should not be used in MRI environments as it may not function properly or could pose safety risks.