Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095686563
• Version / Model: 3034-4
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2023-08-09
• Public Version: 1
• Public Version Date: 2023-08-17
• Public Version Status: New
• Public Device Record Key: fcd198af-3dd6-4947-850a-7835fc77d8cc

Device Description

Cryogenic Vials, 4.0ml, Sterile, Internal Threads, Attached Screwcap with O-ring seal, RB, SS, PG, WS

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
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64783	Microbial cryotube IVD	A vial containing porous glass or synthetic polymer beads and/or a liquid cryoprotectant intended to be used for the cryopreservation, storage, and subsequent retrieval of clinical microbial isolates (e.g., bacteria, fungi) for in vitro diagnostic applications. The container enables preservation and storage of the microbial specimens at sub-zero temperatures for extended periods. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840095686730	GS1	case	4	In Commercial Distribution
Primary	00840095686563	GS1
Unit of Use	00840095688048	GS1