BD A-Line™ Arterial Blood Collection Syringe

Basic Information

• Brand Name: BD A-Line™ Arterial Blood Collection Syringe
• Primary DI: 50382903643788
• Version / Model: 364378
• Catalog Number: 364378
• Company Name: Becton, Dickinson U.K. Limited
• Labeler DUNS: 225931062
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-04-02
• Public Version: 1
• Public Version Date: 2024-04-10
• Public Version Status: New
• Public Device Record Key: 22ebf478-2c8c-4822-8737-b2c3d3bfa2a2

Device Description

SYR ABG ALINE 3(1) LL CE

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57894	Blood gas syringe IVD, lithium heparin	A sterile glass or plastic syringe, without a pre-attached needle, containing the anticoagulant lithium heparin intended to be used for the collection, and preservation and/or transport, of blood for blood gas determination and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00382903643783	GS1
Primary	50382903643788	GS1

Premarket Submissions

Submission Number	Supplement Number
K202446	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature