AccessGUDID - DEVICE: ClampingAdapter - red

GUDID

Device Identifier (DI) Information

Brand Name: ClampingAdapter - red -
Version or Model: 001151-37U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001151-37U
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223016081
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: ClampingAdapter - red - sterile

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?
16858	Catheter injection port	A device intended to be placed on the Luer end of a catheter or intravenous (IV) tubing as a site of injection of substances into the in situ catheter/tubing. It is also intended to be used as a heparin lock by keeping the heparin flush solution in the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSO	CATHETER, CONDUCTION, ANESTHETIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172777	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: 551de4ac-fdce-44c1-bb19-cf093a77ea1c
Public Version Date: September 30, 2020
Public Version Number: 5
DI Record Publish Date: May 22, 2018