Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 29120049200652
• Version / Model: 454322H
• Catalog Number: 454322H
• 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: 4
• Public Version Date: 2024-01-09
• Public Version Status: Update
• Public Device Record Key: 07d2129a-80d3-4741-a16b-69d396c0878c
• Distribution End Date: 2024-01-08

Device Description

VACUETTE® TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged, High Altitude

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
47592	Evacuated blood collection tube IVD, anticoagulant	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. 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 lead, toxicology, nutritional-chemistry, and other 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
Package	39120049200659	GS1		24	Not in Commercial Distribution	2024-01-08
Primary	29120049200652	GS1
Unit of Use	19120049200655	GS1

Premarket Submissions

Submission Number	Supplement Number
K971221	000

Storage Conditions

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