Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 29120049204568
• Version / Model: 455040P
• Catalog Number: 455040P
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2024-02-07
• Public Version Status: Update
• Public Device Record Key: 2b95d42f-836b-4ce9-82e3-f9f76bc28437
• Distribution End Date: 2024-02-07

Device Description

VACUETTE® TUBE 8 ml K2E K2EDTA Separator 16x100 lavender cap-yellow ring, non-ridged, USA

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
PJE	Blood/plasma collection device for DNA testing	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47587	Evacuated blood collection tube IVD, anticoagulant/separator	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], 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., testing plasma in molecular diagnostics and viral load detection). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	39120049204565	GS1		24	Not in Commercial Distribution	2024-02-07
Primary	29120049204568	GS1
Unit of Use	19120049204561	GS1

Premarket Submissions

Submission Number	Supplement Number
K012043	000

Storage Conditions

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