Vacuette

Basic Information

• Brand Name: Vacuette
• Primary DI: 29120049208146
• Version / Model: 484528
• Catalog Number: 484528
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-12-15
• Public Version: 1
• Public Version Date: 2023-12-25
• Public Version Status: New
• Public Device Record Key: 29bc062b-a1e1-4021-a51b-2785bdc2316d

Device Description

VACUETTE® TUBE 2 ml FX Sodium Fluoride / Potassium Oxalate 13x75 grey cap-white ring, G-barcode label, PREMIUM

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
47591	Evacuated blood collection tube IVD, anticoagulant/antiglycolytic	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), ammonium oxalate, potassium oxalate, sodium heparin, sodium citrate], and an antiglycolytic agent (e.g., sodium fluoride, lithium iodoacetate). 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 glucose or lactate 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	39120049208143	GS1		24	In Commercial Distribution
Primary	29120049208146	GS1
Unit of Use	19120017571169	GS1

Premarket Submissions

Submission Number	Supplement Number
K971239	000

Storage Conditions

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