Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 29120049208207
• Version / Model: 454493P
• Catalog Number: 454493P
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-03-19
• Public Version: 1
• Public Version Date: 2020-03-27
• Public Version Status: New
• Public Device Record Key: 3eaac059-27bf-4c1c-b27c-7e284a1c5f37

Device Description

VACUETTE® TUBE 3 ml LH Lithium Heparin Separator 13x75 mint green cap-yellow ring, non-ridged

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
46054	Evacuated blood collection tube IVD, lithium heparin/gel separator	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, the anticoagulant lithium heparin and a gel to separate 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	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	39120049208204	GS1		24	In Commercial Distribution
Primary	29120049208207	GS1
Unit of Use	19120049208200	GS1

Premarket Submissions

Submission Number	Supplement Number
K960857	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius