Tempo

Basic Information

• Brand Name: Tempo
• Primary DI: 00885325001426
• Version / Model: 343105
• Company Name: i-SENS, Inc.
• Labeler DUNS: 688840958
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-02-17
• Public Version: 1
• Public Version Date: 2021-02-25
• Public Version Status: New
• Public Device Record Key: a5c4dd2d-ec41-41eb-8cbe-b5f31877c498

Device Description

Tempo Blood Glucose Test Strip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
53307	Glucose IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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	10885325001423	GS1	Case Pack	35	In Commercial Distribution
Primary	00885325001426	GS1
Package	20885325001420	GS1	Master Case Carton	10	In Commercial Distribution
Unit of Use	50885325001414	GS1

Premarket Submissions

Submission Number	Supplement Number
K192859	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 34 – 86 Degrees Fahrenheit