AccessGUDID - DEVICE: CLAMPING ADAPTOR (04048223049853)

GUDID

Device Identifier (DI) Information

Brand Name: CLAMPING ADAPTOR
Version or Model: 001163-38C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001163-38C
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223049853
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 14048223033088

Device Description: 001163-38C

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?
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
Storage Environment Humidity: between 10 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: ca3ad397-5fc7-4fe0-b3d1-10889d7df7e1
Public Version Date: April 12, 2021
Public Version Number: 1
DI Record Publish Date: April 02, 2021