AimStrip Tandem blood glucose test strips

Basic Information

• Brand Name: AimStrip Tandem blood glucose test strips
• Primary DI: 00695684775506
• Version / Model: ILM-0001A
• Company Name: GERMAINE LABORATORIES, INC
• Labeler DUNS: 176458115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-13
• Public Version: 2
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 5db1f632-16e6-450c-8dc5-baccdc068d48

Device Description

AimStrip Tandem blood glucose test strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00695684775506	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130295	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit