VACUETTE

Basic Information

• Brand Name: VACUETTE
• Primary DI: 19120049206725
• Version / Model: 453032
• Catalog Number: 453032
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-18
• Public Version: 4
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 2ccf3bf5-fcf2-45e7-bb92-cc1ea8c70f50

Device Description

Urine CCM Set VACUETTE® Urine CCM Tube + Urine Transfer Device (455243+450751), single-packed, Conical Base, 9 ml, 16x100

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSM	CULTURE MEDIA, NON-PROPAGATING TRANSPORT	Microbiology	866.2390	1
LIO	Device, specimen collection	Microbiology	866.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58156	Urine transfer IVD, sterile	A sterile plastic adaptor or dedicated transfer device, intended to be used to assist with the aseptic transfer of a urine specimen from the primary collection container to an evacuated urine specimen container for subsequent culture, analysis, and/or other investigation. This is a single-use device.	No	Active
58151	Evacuated urine specimen container IVD, preservative	A covered receptacle containing a pre-measured amount of vacuum and one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	29120049206722	GS1		300	In Commercial Distribution
Primary	19120049206725	GS1

Storage Conditions

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