K-number	K252079
Device name	Disposable Infusion Bag for Parenteral Nutrition
Applicant	Beijing L&Z Medical Technology Development Co., Ltd.
Product code	KPE
Device class	Class II
Decision date	Apr 2, 2026
Decision	Substantially Equivalent
Regulation	880.5025

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Disposable Infusion Bag for Parenteral Nutrition is a container designed for compounding, storing, and administering parenteral nutrition solutions to patients via intravenous infusion sets. The device is not intended for fluid storage lasting 24 hours or longer.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to ISO 13485 quality management system requirements, including design controls (clause 7.3), nonconforming product procedures (clause 8.3), corrective actions (clause 8.5.2), and preventative actions (clause 8.5.3).

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Disposable Infusion Bag for Parenteral Nutrition

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