| Primary Device ID | 00682607001675 |
| NIH Device Record Key | fe23e44f-854c-464d-a33f-0b30d2253be5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | On Call Express II Glucose Monitoring System |
| Version Model Number | G117-10A |
| Catalog Number | 757107 |
| 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 |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| 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 at 10-90% Relative Humidity. Keep out of direct sunlight. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00682607001675 [Direct Marking] |
| GS1 | 00682607571079 [Primary] |
| GS1 | 00682607571086 [Primary] |
| GS1 | 10682607571076 [Package] Contains: 00682607571079 Package: Case [4 Units] In Commercial Distribution |
| GS1 | 10682607571083 [Package] Contains: 00682607571086 Package: Case [4 Units] In Commercial Distribution |
| GS1 | 20682607571073 [Package] Contains: 10682607571076 Package: Carton [6 Units] In Commercial Distribution |
| GS1 | 20682607571080 [Package] Contains: 10682607571083 Package: Carton [6 Units] In Commercial Distribution |
| CGA | GLUCOSE OXIDASE, GLUCOSE |
| NBW | System, test, blood glucose, over the counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-24 |
| Device Publish Date | 2019-12-16 |
| 00682607001675 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G |
| 20682607571141 | Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 100 lancets (30G) |