Central Venous Catheter Kit

FDA UDI

Class II (US FDA UDI)

by Bioptimal International Pte. Ltd.

Identity

Trade Name: Central Venous Catheter Kit FDA UDI
Generic Name: Central venous catheterization kit, short-term FDA UDI
Model / Reference: CV-501-16 FDA UDI

Identifiers

Catalog Number: 25-000009-03 FDA UDI
Primary DI / UDI-DI: 08886483505636 FDA UDI
FDA Product Code: FOZ FDA UDI
GMDN Term: Central venous catheterization kit, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Central venous catheterization kit, short-term

Central Venous Catheter Kit by Bioptimal International Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bioptimal International Pte. Ltd.

Sources (1)

FDA UDI ea5e136a-ef3f-4bb1-9928-92960f9e036b 34 fields · synced Jun 8, 2026