Dario Super Saver MIB-Supplies

Basic Information

• Brand Name: Dario Super Saver MIB-Supplies
• Primary DI: 00850065006659
• Version / Model: 1216-05
• Company Name: LABSTYLE INNOVATION LTD
• Labeler DUNS: 600039072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-15
• Public Version: 1
• Public Version Date: 2021-07-23
• Public Version Status: New
• Public Device Record Key: f6851fd2-ffec-4472-9160-39c8d9501d7b

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• 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: Yes
• 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
53302	Glucose IVD, kit, enzyme spectrophotometry, rapid	A collection of reagents, and sometimes other associated materials, intended to be used for the quantitative measurement of glucose in a clinical specimen within a short period relative to standard laboratory testing procedures, using an enzyme spectrophotometry method. It is available in a variety of forms (e.g., strips, cartridges, micro-cassettes) and may be used in the laboratory, at the point-of-care, and/or in the home.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850065006659	GS1

Premarket Submissions

Submission Number	Supplement Number
K150817	000