AccessGUDID - DEVICE: Filter cannula NRFit (04048223070598)

GUDID

Device Identifier (DI) Information

Brand Name: Filter cannula NRFit
Version or Model: 001163-38Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001163-38Y
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223070598
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Filter cannula NRFit 18G x 50mm, 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":	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?
31245	Anaesthesia conduction filter	A sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction 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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 18.0 Gauge
Length: 50.0 Millimeter

Device Record Status

Public Device Record Key: 125a1b27-f82d-4534-9474-6cf0c30e02f3
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025