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FDA 510(k)

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

K-Number: K001461 · 2000-09-11

ApplicantBiometrix , Ltd.
Decision Date2000-09-11
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET is the device name listed in this FDA 510(k) record. The listed applicant is Biometrix , Ltd.. It received FDA 510(k) clearance on 2000-09-11 under 510(k) number K001461. 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 TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET?

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET is a medical device that received FDA 510(k) clearance on 2000-09-11. The listed applicant is Biometrix , Ltd.. The 510(k) number is K001461.

When did TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET receive FDA 510(k) clearance?

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET received FDA 510(k) clearance on 2000-09-11, under 510(k) number K001461.

Who is the listed applicant for TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET?

The FDA 510(k) record lists Biometrix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET?

The FDA product code for TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET is KPE.

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Other records listing Biometrix , 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.

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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

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

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