AccessGUDID - DEVICE: Clamping Adapter NRFit -yellow- (14048223029982)

GUDID

Device Identifier (DI) Information

Brand Name: Clamping Adapter NRFit -yellow-
Version or Model: 001163-37V
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001163-37V
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223029982
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Clamping Adapter NRFit -yellow- 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?
63607	NRFit/epidural catheter linear connector	A small, non-powered, noninvasive, tubular device with an NRFit connection at one end (a connection designed specifically for neuraxial applications according to ISO 80369-6) and an epidural catheter adapting mechanism at the other end, intended to connect an external device with an NRFit 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
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: e2f96143-e7a3-4605-aaaf-7ba4472a09cd
Public Version Date: March 17, 2025
Public Version Number: 5
DI Record Publish Date: May 22, 2018