Glucertain

Basic Information

• Brand Name: Glucertain
• Primary DI: 00850031608696
• Version / Model: 30185
• Catalog Number: 30185
• Company Name: CELLERA LLC
• Labeler DUNS: 960091929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-28
• Public Version: 1
• Public Version Date: 2023-04-05
• Public Version Status: New
• Public Device Record Key: a70653e1-8cec-49cd-a82c-8a338a75cb86

Device Description

Glucose Control Solution, Normal, 50/box, 12 boxes/case

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850031608702	GS1	Box	50	In Commercial Distribution
Primary	00850031608696	GS1
Package	10850031608709	GS1	Case	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112901	000