AccessGUDID - DEVICE: Gardian 25 mm Syringe Filter (05034480315472)

GUDID

Device Identifier (DI) Information

Brand Name: Gardian 25 mm Syringe Filter
Version or Model: 6094184
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6094184
Company Name: Pall International Sàrl

Primary DI Number: 05034480315472
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 485050483 *Terms of Use

Device Description: 25mm syringe filter with 5.0 micron low protein binding Versapor® membrane

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?
46817	Syringe filter, clinical	A sterile membrane intended to be used in a syringe or connected to a syringe (e.g., between the syringe and the needle or cannula) to sterilize, ultraclean, or clarify medicinal solutions during pharmaceutical preparation or patient injection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPB	Filter, infusion line

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: 5 Micrometer

Device Record Status

Public Device Record Key: 2bbe40db-ad16-4077-bdbc-f1fc368ed1b9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 20, 2016