Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095684965
• Version / Model: 3856L-A-TP
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2023-07-05
• Public Version: 1
• Public Version Date: 2023-07-13
• Public Version Status: New
• Public Device Record Key: 7c47e54d-9bc7-46b0-a8ae-ef856e8c2e4b

Device Description

120mL collection cup, bulk sterile, yellow cap, w/ temperature strip

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: Yes
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00840095687591	GS1
Primary	00840095684965	GS1