Gardian 25 mm Syringe Filter

Basic Information

• Brand Name: Gardian 25 mm Syringe Filter
• Primary DI: 05034480315465
• Version / Model: 6764192
• Catalog Number: 6764192
• Company Name: Pall International Sàrl
• Labeler DUNS: 485050483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-07-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 64edd4ef-e371-4133-920f-df0c1b8a5e4e

Device Description

25mm syringe filter with 0.2 micron low protein binding Supor® membrane

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05034480315465	GS1
Unit of Use	25034480315469	GS1

Customer Contacts

• Phone: [phone] ext. 5164843600
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Pore Size	0.2	Micrometer