Drainage Bag, 4000 ML

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770557 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Prefilled Pulsator Syringe

  Class II

  FDA 510(k) K811009 Active Cleared 12 Jun 1981

• Epidural Trays

  Class II

  FDA 510(k) K842095 Active Cleared 3 Jul 1984

• Syringe, Blood Sampling, Arterial, #4015

  Class II

  FDA 510(k) K770852 Active Cleared 14 Jul 1977

• Arterial Blood Sampling Kits

  Class I

  FDA 510(k) K841486 Active Cleared 23 May 1984

• Tray, Blood Sampling (Pulsator II)

  Class II

  FDA 510(k) K760086 Active Cleared 16 Jul 1976

• Sani Catch Ba

  Class I

  FDA 510(k) K833814 Active Cleared 19 Mar 1984

See all devices from Concord Laboratories, Inc. →

• What is the primary use of the 4000 mL drainage bag?

  The 4000 mL drainage bag is designed to collect and contain urine drained from patients using an indwelling catheter. It is intended for both short-term and continuous urinary drainage, helping maintain patient comfort and hygiene by safely managing urinary output in clinical settings like hospitals, urology, and gastroenterology departments.

• How is the drainage bag supplied, and what are its key features?

  The drainage bag is supplied sterile and as a single-use disposable device, specifically for bedside use. It features a 4000 mL capacity, ensuring it can accommodate larger urinary outputs without frequent emptying. The sterile packaging and single-use design help prevent contamination and reduce infection risks.

• Is the drainage bag reusable, and if not, why?

  No, the drainage bag is intended for single-use only. This design choice is critical for infection control, as reuse could introduce pathogens from previous patients, compromising patient safety and hygiene standards in clinical environments.

• What are the recommended storage conditions for this device?

  The drainage bag should be stored in its original, unopened sterile packaging until ready for use. It must be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage to preserve sterility and functionality.

• What regulatory approvals does this device hold?

  The drainage bag has received FDA 510(k) clearance (K770557) as substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulations (876.5250), indicating it has undergone rigorous review for safety and effectiveness in its intended use.