Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 29120049204643
• Version / Model: 456044P
• Catalog Number: 456044P
• 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: 5
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 65dfe326-1989-4f8b-8a96-800fe2d8f5e4

Device Description

VACUETTE® TUBE 5 ml CAT Serum Separator Clot Activator 13x100 black 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
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41128	Evacuated blood collection tube IVD, clot activator/separator	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator, and a separator (e.g., gel) to separate blood serum 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., blood serum 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
Package	39120049204640	GS1		24	In Commercial Distribution
Primary	29120049204643	GS1
Unit of Use	19120049204646	GS1

Premarket Submissions

Submission Number	Supplement Number
BK040066	000
BK050028	000
K960858	000
K983952	000

Storage Conditions

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