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Clearlink/Duo-Vent

FDA UDI

Class II (US FDA UDI)

by Baxter International Inc.

Identity

Trade Name
CLEARLINK/DUO-VENT FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Device Name
Non-DEHP, Secondary Medication Set with DUO-VENT Spike, Hanger, Male Luer Lock Adapter FDA UDI
Model / Reference
2H7462 FDA UDI
Description
Non-DEHP, Secondary Medication Set with DUO-VENT Spike, Hanger, Male Luer Lock Adapter FDA UDI

Identifiers

Catalog Number
2H7462 FDA UDI
Primary DI / UDI-DI
00085412048543 FDA UDI
510(k) Number
K203609 FDA UDI
K961225 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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

No

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: Basic intravenous administration set, noninvasive

Clearlink/Duo-Vent by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic intravenous administration set, noninvasive.

Cleared under the same submission

K203609 also covers:

K961225 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baxter International Inc.

Sources (1)

  • FDA UDI b07053b5-d5fb-4283-91d8-ed955bf1f6a5 36 fields · synced May 31, 2026