AccessGUDID - DEVICE: Filter (04048223120316)

GUDID

Device Identifier (DI) Information

Brand Name: Filter
Version or Model: 001151-62
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001151-62
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223120316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Filter 0,2µm, 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
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
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
Pore Size: 0.2 Micrometer

Device Record Status

Public Device Record Key: 51d29a93-cc2c-4fb8-9bba-305b51d985fd
Public Version Date: April 14, 2025
Public Version Number: 1
DI Record Publish Date: April 04, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
04048223120323	10	04048223120316		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 770-493-6832
Email: info@pajunk-usa.com

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