Urine Collection Tube

Basic Information

• Brand Name: Urine Collection Tube
• Primary DI: 06974481833492
• Version / Model: Urinalysis No Additive Tube
• Company Name: Guangzhou Improve Medical Instruments Co., Ltd.
• Labeler DUNS: 554555378
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-09
• Public Version: 1
• Public Version Date: 2022-10-17
• Public Version Status: New
• Public Device Record Key: 60c3f9cf-d42c-44d0-9a52-5f1402a6d49f

Device Description

8mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	Container, Specimen, Sterile	Pathology	864.3250	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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16974481833499	GS1		50	In Commercial Distribution
Primary	06974481833492	GS1
Package	46974481833490	GS1		20	In Commercial Distribution