Globe Scientific

Basic Information

• Brand Name: Globe Scientific
• Primary DI: 00840095604390
• Version / Model: 167313
• Company Name: GLOBE SCIENTIFIC INC.
• Labeler DUNS: 106793995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2019-11-26
• Public Version: 1
• Public Version Date: 2019-12-04
• Public Version Status: New
• Public Device Record Key: 59960cb4-f31d-439b-a673-205574ef2e33

Device Description

Capillary tube, K2EDTA (1.8mg/mL), 100/Vial, 10 Vials/Box ** SPECIAL ORDER ITEM **

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GIO	Tube, Collection, Capillary Blood	Hematology	864.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57892	Capillary blood collection tube IVD, K2EDTA	A non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840095604390	GS1
Unit of Use	00840095610681	GS1