AccessGUDID - DEVICE: ClampingAdapter - white

GUDID

Device Identifier (DI) Information

Brand Name: ClampingAdapter - white -
Version or Model: 001151-38C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001151-38C
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223069547
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: ClampingAdapter - white - steril

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:	Yes
Prescription Use (Rx):	No
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?
63606	Luer/epidural catheter linear connector	A small, non-powered, noninvasive tubular device with a Luer connection (either lock or slip) at one end and an epidural catheter adapting mechanism at the other end, intended to connect an external device with a Luer connection (e.g., syringe) with an epidural catheter with no pre-existing connector. It is designed to connect over the epidural catheter and seal the connection with either an integrated clamping mechanism or by means of an adhesive port. It does not incorporate a valve, tubing nor puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction kit

FDA Premarket Submission

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

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
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 15726cb7-0703-493d-87ed-a34221a1d693
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025