AccessGUDID - DEVICE: Gardian 25 mm Syringe Filter (05034480315465)

GUDID

Device Identifier (DI) Information

Brand Name: Gardian 25 mm Syringe Filter
Version or Model: 6764192
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6764192
Company Name: Pall International Sàrl

Primary DI Number: 05034480315465
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 0.2 micron low protein binding Supor® 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":	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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

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Product Code	Product Code Name
FMF	Syringe, piston

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Pore Size: 0.2 Micrometer

Device Record Status

Public Device Record Key: 64edd4ef-e371-4133-920f-df0c1b8a5e4e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 20, 2016