On Call Express Blood Glucose Test Strips

GUDID 00682607000098

Blood Glucose Test Strips, vial of 50 strips

ACON LABORATORIES, INC.

Home-use/point-of-care blood glucose monitoring system IVD Home-use/point-of-care blood glucose monitoring system IVD
Primary Device ID00682607000098
NIH Device Record Keyba5e40ac-4e3e-43e4-a27a-043327c917b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOn Call Express Blood Glucose Test Strips
Version Model NumberG135-10D
Company DUNS781100966
Company NameACON LABORATORIES, INC.
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)838-9502
Emailsupport@aconlabs.com
Phone+1(800)838-9502
Emailsupport@aconlabs.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100682607000098 [Primary]
GS100682607000111 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGLUCOSE OXIDASE, GLUCOSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [On Call Express Blood Glucose Test Strips]

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

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