AccessGUDID - DEVICE: Perifix® (04046964183218)

GUDID

Device Identifier (DI) Information

Brand Name: Perifix®
Version or Model: 415000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 415000
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964183218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: PERIFIX® 0.2 µm Flat Epidural Filter - for use with all PERIFIX catheters and PERIFIX PinPad™

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):	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
FMF	Syringe, piston
CAZ	Anesthesia conduction kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Pore Size: 0.2 Micrometer

Device Record Status

Public Device Record Key: 9b8498b0-3d1c-475a-a709-5e039f333814
Public Version Date: September 21, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016