AccessGUDID - DEVICE: CLEARLINK/DUO-VENT (00085412565750)

GUDID

Device Identifier (DI) Information

Brand Name: CLEARLINK/DUO-VENT
Version or Model: 2R8480
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2R8480
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412565750
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Non-DEHP Solution Set with DUO-VENT Spike, 0.2 Micron Downstream Filter, Luer Activated Valve Male Luer Lock Adapter with Retractable Collar, 103" 2.6m approx., 10 drops/mL approx.

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?
35072	Intravenous line filter	A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. 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 [?]
K153158	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: 02fab22e-1076-4353-9c82-7a8493f2abae
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 11, 2017