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FDA 510(k)

Disposable Infusion Bag for Parenteral Nutrition

K-Number: K222622 · 2023-02-16

ApplicantBeijing L&Z Medical Technology Development Co., Ltd.
Decision Date2023-02-16
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Infusion Bag for Parenteral Nutrition is the device name listed in this FDA 510(k) record. The listed applicant is Beijing L&Z Medical Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K222622. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Infusion Bag for Parenteral Nutrition?

Disposable Infusion Bag for Parenteral Nutrition is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Beijing L&Z Medical Technology Development Co., Ltd.. The 510(k) number is K222622.

When did Disposable Infusion Bag for Parenteral Nutrition receive FDA 510(k) clearance?

Disposable Infusion Bag for Parenteral Nutrition received FDA 510(k) clearance on 2023-02-16, under 510(k) number K222622.

Who is the listed applicant for Disposable Infusion Bag for Parenteral Nutrition?

The FDA 510(k) record lists Beijing L&Z Medical Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Infusion Bag for Parenteral Nutrition?

The FDA product code for Disposable Infusion Bag for Parenteral Nutrition is KPE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05537389Intravenous Neonatal Central Access Safety TrialRECRUITINGNCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITING

Other records listing Beijing L&Z Medical Technology Development Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252079Disposable Infusion Bag for Parenteral NutritionK240052Disposable Enteral Feeding Sets

Related Devices (Code: KPE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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