EXTENSION SET

Basic Information

• Brand Name: EXTENSION SET
• Primary DI: 00085412639338
• Version / Model: 2N3357
• Catalog Number: 2N3357
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 005083209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-21
• Public Version: 1
• Public Version Date: 2020-10-29
• Public Version Status: New
• Public Device Record Key: 7ec279fc-e9fb-439f-acce-54799d65ce12

Device Description

Micro-Volume Extension Set with 0.2 Micrometer 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
FPA	Set, administration, intravascular	General Hospital	880.5440	2
FPB	Filter, infusion line	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	50085412639333	GS1	CASE	50	In Commercial Distribution
Primary	00085412639338	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192366	000

Device Sizes

Type	Value	Unit	Text
Pressure	45	Pound per Square Inch
Length	2000000000000000	Femtometer
Total Volume	0.88	Milliliter

Storage Conditions

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