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Repair Kit

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
REPAIR KIT FDA UDI
Generic Name
Vascular catheterization support/maintenance kit, non-medicated FDA UDI
Device Name
REPAIR KIT FDA UDI
Model / Reference
RPK-01 FDA UDI
Description
REPAIR KIT FDA UDI

Identifiers

Primary DI / UDI-DI
00884908039856 FDA UDI
FDA Product Code
NFK FDA UDI
GMDN Term
Vascular catheterization support/maintenance kit, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular catheterization support/maintenance kit, non-medicated

Repair Kit by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheterization support/maintenance kit, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI 381704f8-c083-41c3-b3f4-1eb8fb3f59bf 34 fields · synced Jun 8, 2026