AccessGUDID - DEVICE: NiniFilter NRFit (14048223031312)

GUDID

Device Identifier (DI) Information

Brand Name: NiniFilter NRFit
Version or Model: 001163-38K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001163-38K
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 14048223031312
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: No description.

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?
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
BSN	FILTER, CONDUCTION, ANESTHETIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190663	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: 656c7f99-765c-485f-a056-57af18ed1756
Public Version Date: March 17, 2025
Public Version Number: 3
DI Record Publish Date: July 22, 2020