Mediflex Drainage Bag

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843126 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Mediflex Transducer Protector

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  FDA 510(k) K863496 Active Cleared 23 Sep 1986

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  FDA 510(k) K915140 Active Cleared 11 Feb 1992

• I.V. Administration Set

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  FDA 510(k) K852106 Active Cleared 7 Jun 1985

• Mediverse Parenteral Nutrition Bag

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  FDA 510(k) K891077 Active Cleared 24 May 1989

• Hemodialysis Transducer Protector

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  FDA 510(k) K900841 Active Cleared 15 May 1990

• Mediflex Disposable Tubing Clamp

  Class II

  FDA 510(k) K854346 Active Cleared 18 Nov 1985

See all devices from Mediflex Intl. →

• What is the primary purpose of the Mediflex Drainage Bag?

  This device is designed to function as a collector for urine and associated accessories for patients using indwelling catheters. It provides a dedicated vessel for the collection of fluid.

• What is the fluid capacity of this drainage bag?

  The Mediflex Drainage Bag has a maximum capacity of 2000mL, allowing for the collection of urine volumes up to this specified limit.

• Is the Mediflex Drainage Bag supplied as a sterile product?

  No, this device is supplied as a non-sterile product. Users should follow appropriate clinical protocols for handling non-sterile medical equipment in a catheterization setting.

• What is the regulatory status of this device?

  The Mediflex Drainage Bag has received FDA 510(k) clearance under the number K843126. This indicates the device has been reviewed and cleared for use as a collector for indwelling catheters.