VACUETTE

Basic Information

• Brand Name: VACUETTE
• Primary DI: 19120049209085
• Version / Model: 453042
• Company Name: Greiner Bio-One GmbH
• Labeler DUNS: 303639066
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-16
• Public Version: 3
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 209d403d-38c8-4c7a-b16f-104ce4e96ca4

Device Description

Urine CCM / Z Urine No Additive Set with Beaker <(>&<)> Towelette consisting of: Item No. 454486 VACUETTE® TUBE 4 ml Urine CCM, 13x75, Round Base Item No. 455028 VACUETTE® TUBE 9 ml Z Urine No Additive, 16x100, Conical Base Item No. 724310 Urine Beaker with integrated Transfer Device 100 ml Castile Soap Towelette single-packed

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: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
58158	Evacuated urine specimen container IVD, no additive	A covered receptacle containing a pre-measured amount of vacuum with no additives, 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
47776	General specimen container IVD, no additive, sterile	A sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.	No	Obsolete
47588	Evacuated blood collection tube IVD, K3EDTA	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant tripotassium ethylene diamine tetraacetic acid (K3EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., whole blood haematology such as complete blood count (CBC), and quantitative drug assay determinations]. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	29120049209082	GS1		50	In Commercial Distribution
Primary	19120049209085	GS1

Storage Conditions

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