Filter Sampler Blood Serum Filter

Basic Information

• Brand Name: Filter Sampler Blood Serum Filter
• Primary DI: 10817139020109
• Version / Model: IB Model
• Catalog Number: 6249
• Company Name: POREX CORPORATION
• Labeler DUNS: 186972733
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 3
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: bdd5cea4-fdf0-4995-927e-304c9f92ee4a

Device Description

16mm x 2 3/4" Filter Sample Blood Serum Filter IB Model

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57895	Evacuated blood collection tube IVD, no additive/metal-free	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum with no additive and free of any metals. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum chemistry determinations including trace elements, serology, and toxicology). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10817139020109	GS1
Unit of Use	00817139020102	GS1
Package	20817139020106	GS1		40	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 140 Degrees Fahrenheit