FLUID SYSTEMS ACCESSORIES

Basic Information

• Brand Name: FLUID SYSTEMS ACCESSORIES
• Primary DI: 00085412639444
• Version / Model: 2N3368
• Catalog Number: 2N3368
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 005083209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-30
• Public Version: 3
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: c6326f18-4c34-4f30-a82d-75308dd0a008

Device Description

Air Eliminating 1.2 micrometer Solution Filter

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FPB	Filter, infusion line	General Hospital	880.5440	2
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412639449	GS1	CASE	50	In Commercial Distribution
Primary	00085412639444	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192366	000

Device Sizes

Type	Value	Unit	Text
Pressure	29	Pound per Square Inch
Total Volume	0.8	Milliliter
Pore Size	0.000001200000	Meter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at Room Temperature, Keep dry, Keep away from sunlight (or heat)