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FDA 510(k)

GRI-BAG, GRI-BAG AP

K-Number: K033916 · 2003-12-30

ApplicantLaboratorios Grifols, S.A.
Decision Date2003-12-30
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GRI-BAG, GRI-BAG AP is the device name listed in this FDA 510(k) record. The listed applicant is Laboratorios Grifols, S.A.. It received FDA 510(k) clearance on 2003-12-30 under 510(k) number K033916. 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 GRI-BAG, GRI-BAG AP?

GRI-BAG, GRI-BAG AP is a medical device that received FDA 510(k) clearance on 2003-12-30. The listed applicant is Laboratorios Grifols, S.A.. The 510(k) number is K033916.

When did GRI-BAG, GRI-BAG AP receive FDA 510(k) clearance?

GRI-BAG, GRI-BAG AP received FDA 510(k) clearance on 2003-12-30, under 510(k) number K033916.

Who is the listed applicant for GRI-BAG, GRI-BAG AP?

The FDA 510(k) record lists Laboratorios Grifols, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRI-BAG, GRI-BAG AP?

The FDA product code for GRI-BAG, GRI-BAG AP is KPE.

Other records listing Laboratorios Grifols, S.A. 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.

K162216GRI-FILL PERISTALTIC SETK102590FLEBOSET DOUBLEK093182SET GRI-FILL 3.0K082752QUICKPINK050339SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLEK040456FLEBOSET MULTIPLE

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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

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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