BD Microtainer® PST™ Tubes with LH (Lithium Heparin) - Amber

Basic Information

• Brand Name: BD Microtainer® PST™ Tubes with LH (Lithium Heparin) - Amber
• Primary DI: 30382903659877
• Version / Model: 365987
• Catalog Number: 365987
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 001292192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 5
• Public Version Date: 2024-02-27
• Public Version Status: Update
• Public Device Record Key: 08144cef-b507-4b2e-8a19-7c50bf1c92c5

Device Description

TUBE MICRO W/MICROGARD PST MTGN/AMB

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
58145	Non-evacuated blood collection tube IVD, anticoagulant/separator	A non-evacuated glass or plastic tube, sealed with a stopper, containing an anticoagulant [e.g., lithium heparin, ethylenediaminetetraacetic acid (EDTA)] and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382903659877	GS1
Unit of Use	00382903659876	GS1
Package	50382903659871	GS1	Case	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K991702	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius