AccessGUDID - DEVICE: CLEARLINK/CONTROL-A-FLO (00085412046396)

GUDID

Device Identifier (DI) Information

Brand Name: CLEARLINK/CONTROL-A-FLO
Version or Model: 2C8891
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2C8891
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412046396
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Extension Set with CONTROL-A-FLO Regulator, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35894	Medical tubing clip/clamp, temporary, dial-calibrated	A non-sterile manual device designed to control the infusion rate through gravity intravenous administration infusion sets. It typically consists of a mechanism that regulates the flow using a calibrated dial that permits control of the flow rate in a given range (e.g., from a few to 250 ml/h); it may also include a lateral clamp for temporary interruption of the infusion and/or a check valve to permit parallel infusion. The device is used in-line with gravity infusion administration sets. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121634	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7e50e19-32e9-473d-92a7-685e33304bd9
Public Version Date: June 05, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016