ONE-CARE 4002
GUDID 00810008210499
ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE PRO system can be used by healthcare professionals in multi-patient setting or at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.
MediVena, LLC
Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use| Primary Device ID | 00810008210499 |
| NIH Device Record Key | 4812174f-1d0b-487d-9f0e-0baf34a040f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE-CARE |
| Version Model Number | AC500 PRO |
| Catalog Number | 4002 |
| Company DUNS | 080740980 |
| Company Name | MediVena, LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
Customer Support Contacts
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com | |
| Phone | 404-514-2586 |
| jarek.moleda@medivena.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810008210048 [Primary] |
| GS1 | 00810008210499 [Package] Contains: 00810008210048 Package: inner pack [280 Units] In Commercial Distribution |
| GS1 | 00810008210505 [Package] Contains: 00810008210048 Package: case [560 Units] In Commercial Distribution |
FDA Product Code
| NBW | System, Test, Blood Glucose, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2023-09-10 |
On-Brand Devices [ONE-CARE]
| 00810008210994 | ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucos |
| 00810008210512 | ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative meas |
| 00810008210451 | ONE-CARE glucose monitoring system is intended for the quantitative measurement of glucose in fr |
| 00810008210499 | ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitat |
| 00810008210031 | ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose i |
| 00810008212103 | ONE-CARE OPTI Safety Pen Needles 30G x 8mm offer safety solution as the needle is automatically |
| 00810008211939 | ONE-CARE OPTI Safety Pen Needles offer safety solution as the needle is automatically shielded a |
| 00810008212080 | ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutan |
Trademark Results [ONE-CARE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONE-CARE 88267775 not registered Live/Pending |
MediVena, LLC 2019-01-18 |
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