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Clearlink/Control-A-Flo

FDA UDI

Class II (US FDA UDI)

by Baxter International Inc.

Identity

Trade Name
CLEARLINK/CONTROL-A-FLO FDA UDI
Generic Name
Medical tubing clip/clamp, temporary, dial-calibrated FDA UDI
Device Name
Extension Set with CONTROL-A-FLO Regulator, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar FDA UDI
Model / Reference
2C8891 FDA UDI
Description
Extension Set with CONTROL-A-FLO Regulator, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar FDA UDI

Identifiers

Catalog Number
2C8891 FDA UDI
Primary DI / UDI-DI
00085412046396 FDA UDI
510(k) Number
K121634 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Medical tubing clip/clamp, temporary, dial-calibrated 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical tubing clip/clamp, temporary, dial-calibrated

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

Similar devices

Also classified as Medical tubing clip/clamp, temporary, dial-calibrated.

Cleared under the same submission

K121634 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 e7e50e19-32e9-473d-92a7-685e33304bd9 36 fields · synced May 30, 2026