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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
Central venous catheterization kit, short-term FDA UDI
Device Name
INTROFLEX CVC BUNDLE 9FR FDA UDI
Model / Reference
ECVC5930 FDA UDI
Description
INTROFLEX CVC BUNDLE 9FR FDA UDI

Identifiers

Catalog Number
ECVC5930 FDA UDI
Primary DI / UDI-DI
10653160343004 FDA UDI
FDA Product Code
OES FDA UDI
GMDN Term
Central venous catheterization kit, short-term FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Central venous catheterization kit, short-term

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Central venous catheterization kit, short-term.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9721cfee-f870-4925-a074-5fc11e4a65a3 35 fields · synced Jun 8, 2026