Mediverse Parenteral Nutrition Bag

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

510(k) Number

K891077 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Mediflex Transducer Protector

  Class II

  FDA 510(k) K863496 Active Cleared 23 Sep 1986

• Primary Dressing Tray

  Class I

  FDA 510(k) K915140 Active Cleared 11 Feb 1992

• I.V. Administration Set

  Class II

  FDA 510(k) K852106 Active Cleared 7 Jun 1985

• Hemodialysis Transducer Protector

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  FDA 510(k) K900841 Active Cleared 15 May 1990

• Mediflex Disposable Tubing Clamp

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  FDA 510(k) K854346 Active Cleared 18 Nov 1985

• Mediflex Drainage Bag

  Class II

  FDA 510(k) K843126 Active Cleared 4 Oct 1984

See all devices from Mediflex Intl. →

• What is the Mediverse Parenteral Nutrition Bag used for?

  It is used for the delivery of nutritional solutions intravenously, as a Container, I.V., intended for parenteral nutrition in general hospital settings.

• Is the Mediverse Parenteral Nutrition Bag sterile or non-sterile when supplied?

  The device is supplied non-sterile, meaning it requires sterilization by the user before use, as specified in the device description.

• Can the Mediverse Parenteral Nutrition Bag be reused after initial use?

  No, it is designed for single-use only, as stated in the specifications, to prevent contamination and ensure patient safety during parenteral nutrition delivery.

• What regulatory pathway was used for the Mediverse Parenteral Nutrition Bag?

  It received FDA 510(k) clearance under K891077, classified as a Class II device with product code KPE and regulation number 880.5025, based on substantial equivalence to a predicate device.