Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 29120017577007
• Version / Model: 454331
• Catalog Number: 454331
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 8eb05f14-943e-4fb5-8d48-69ffb5fda2b0

Device Description

VACUETTE® TUBE 3.5 ml 9NC Coagulation sodium citrate 3.2% 13x75 light blue cap-black ring, sandwich tube, non-ridged, High Altitude, 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
GIM	Tubes, vacuum sample, with anticoagulant	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42585	Evacuated blood collection tube IVD, sodium citrate	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., for plasma coagulation studies, mononuclear cell preparation). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	39120017577004	GS1		24	In Commercial Distribution
Primary	29120017577007	GS1
Unit of Use	19120017577000	GS1

Premarket Submissions

Submission Number	Supplement Number
K971221	000

Storage Conditions

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