Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095641685
• Version / Model: 108010
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2023-07-03
• Public Version: 1
• Public Version Date: 2023-07-11
• Public Version Status: New
• Public Device Record Key: 3eaefbb4-0a43-4c78-b19b-f8d080c36f2b

Device Description

Container, 24 Hour Urine Collection, 3000mL (3 Liter), Affixed TransferTop Screwcap, Amber

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNI	Container, Specimen, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57919	24-hour urine specimen container IVD, no additive	A capped plastic receptacle, typically 2 to 4 litres, with no additives and intended to be used for the collection, and preservation and/or transport, of urine collected over a 24-hour period for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00840095687300	GS1
Primary	00840095641685	GS1