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FDA 510(k)

VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.

K-Number: K850133 · 1985-02-28

ApplicantConsolidated Medical Equipment, Inc.
Decision Date1985-02-28
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Medical Equipment, Inc.. It received FDA 510(k) clearance on 1985-02-28 under 510(k) number K850133. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.?

VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. is a medical device that received FDA 510(k) clearance on 1985-02-28. The listed applicant is Consolidated Medical Equipment, Inc.. The 510(k) number is K850133.

When did VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. receive FDA 510(k) clearance?

VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. received FDA 510(k) clearance on 1985-02-28, under 510(k) number K850133.

Who is the listed applicant for VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.?

The FDA 510(k) record lists Consolidated Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.?

The FDA product code for VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. is KGX.

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Other records listing Consolidated Medical Equipment, Inc. 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: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, Inc.

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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