On Call Express Blood Glucose Test Strips

GUDID 00692607000081

Home-use/point-of-care blood glucose monitoring system IVD

Primary Device ID	00692607000081
NIH Device Record Key	f3c6e297-c5fc-4e4b-9394-fb0988dd607d
Commercial Distribution Status	In Commercial Distribution
Brand Name	On Call Express Blood Glucose Test Strips
Version Model Number	G135-10D
Company DUNS	781100966
Company Name	ACON LABORATORIES, INC.
Device Count	10
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does n
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place
Special Storage Condition, Specify	Between 0 and 0 *Keep out of direct sunlight
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool, dry place

Device Issuing Agency	Device ID
GS1	00682607000111 [Unit of Use]
GS1	00692607000081 [Primary]

CGA	GLUCOSE OXIDASE, GLUCOSE

Steralize Prior To Use	false
Device Is Sterile	false

00692607000081	Blood Glucose Test Strips, vial of 10 strips
10682607557292	Blood Glucose Test Strips, box of 50 strips
00682607000098	Blood Glucose Test Strips, vial of 50 strips