AccessGUDID - DEVICE: NA (00085412025360)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 5C4527
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5C4527
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00085412025360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilitate peritoneal dialysis set connector insertion into and removal from, Peritoneal Dialysis Solution in plastic container.

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":	No
For Single-Use:	No
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?
32146	Medical tubing clip/clamp, temporary, non-calibrated, reusable	A non-sterile, manual device designed to compress a piece of medical device tubing or tubular container to reversibly occlude its lumen and stop the flow of material within; it is not intended for patient-contact. It has a manual mechanism (e.g., hinging, roller-type, vice-like) whereby pressure on the tube can be applied or removed, however it is not a calibrated device (e.g., it is often a roller type, clip, or screw-clamp). It may be referred to as a clip or a clamp. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKK	CLAMP, LINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: 69540e44-a99f-4488-9a49-15f26a1f0f57
Public Version Date: August 22, 2023
Public Version Number: 4
DI Record Publish Date: March 15, 2019