Primary Device ID | 00682607000012 |
NIH Device Record Key | 0816fbb7-12df-4d2e-82f0-4e83ae23bff8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | On Call Vivid Blood Glucose Monitoring System |
Version Model Number | G115-102 |
Company DUNS | 781100966 |
Company Name | ACON LABORATORIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
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 |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com | |
Phone | +1(800)838-9502 |
support@aconlabs.com |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00682607000012 [Direct Marking] |
GS1 | 00682607556113 [Primary] |
GS1 | 00682607556151 [Primary] |
GS1 | 00682607571017 [Primary] |
GS1 | 00682607571024 [Primary] |
GS1 | 10682607556110 [Package] Contains: 00682607556113 Package: case [4 Units] In Commercial Distribution |
GS1 | 10682607556158 [Package] Contains: 00682607556151 Package: case [4 Units] In Commercial Distribution |
GS1 | 10682607571014 [Package] Contains: 00682607571017 Package: Case [4 Units] In Commercial Distribution |
GS1 | 10682607571021 [Package] Contains: 00682607571024 Package: Case [4 Units] In Commercial Distribution |
GS1 | 20682607556117 [Package] Contains: 10682607556110 Package: carton [6 Units] In Commercial Distribution |
GS1 | 20682607556155 [Package] Contains: 10682607556158 Package: carton [6 Units] In Commercial Distribution |
GS1 | 20682607571011 [Package] Contains: 10682607571014 Package: Carton [6 Units] In Commercial Distribution |
GS1 | 20682607571028 [Package] Contains: 10682607571021 Package: Carton [6 Units] In Commercial Distribution |
JJX | Single (specified) analyte controls (assayed and unassayed) |
NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
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20682607200515 - MISSION U500 URINE ANALYZER | 2024-03-18 URINE ANALYZER with Barcode Reader |
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20682607660289 - Flowflex COVID-19 Antigen Home Test | 2021-11-30 Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5) |