Churchill Parenteral Nutrition Bag - EVA

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

510(k) Number

K870395 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Churchill Haber Point Needle Admin. Set

  Class II

  FDA 510(k) K850420 Active Cleared 24 Apr 1985

• Churchill-Hs Suspended Non-Vented IV Set

  Class II

  FDA 510(k) K854630 Active Cleared 10 Dec 1985

• Churchill-H Extension Tube

  Class II

  FDA 510(k) K854629 Active Cleared 10 Dec 1985

• Churchill Blood Administration Set

  Class II

  FDA 510(k) K864441 Active Cleared 20 Jan 1987

• Churchill-H Vented IV Set W/Metering Chambers

  Class II

  FDA 510(k) K871732 Active Cleared 15 Jun 1987

• Blood Gas Sampler Kit

  Class II

  FDA 510(k) K850958 Active Cleared 10 Apr 1985

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• What is the Churchill Parenteral Nutrition Bag – EVA primarily used for in clinical settings?

  The Churchill Parenteral Nutrition Bag – EVA is designed as an intravenous (I.V.) container for administering parenteral nutrition directly into the bloodstream. It is intended for patients who require total or partial nutritional support when oral intake is inadequate or impossible, such as in hospital settings where patients need intravenous feeding.

• Is the Churchill Parenteral Nutrition Bag – EVA meant for single-use or can it be reused?

  The Churchill Parenteral Nutrition Bag – EVA is explicitly labeled as a sterile, single-use product. It must not be reused to maintain aseptic conditions and ensure patient safety, as reuse could compromise sterility and integrity.

• How is this device cleared for use in the U.S., and what regulatory pathway was followed?

  The Churchill Parenteral Nutrition Bag – EVA was cleared via the Traditional 510(k) pathway by the FDA, as indicated by its FDA_510K authorization. This means it was determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the market with regulatory approval. The device is classified under FDA regulation 880.5025 as a Class II medical device.

• What types of hospitals or clinical environments is this device intended for?

  The device is registered under the General Hospital medical specialty description, meaning it is intended for use in standard hospital settings where intravenous nutrition support is administered. The regulatory submission does not specify niche specialties, so it is broadly applicable to general inpatient care.

• Are there any specific storage or handling instructions mentioned for this device?

  While the provided data does not detail exact storage conditions, the Churchill Parenteral Nutrition Bag – EVA is sterile and must be handled under aseptic conditions before use. This implies it should be stored in a clean, dry environment, protected from contamination, and used within its expiration date to ensure safety and efficacy.