Identity
- Trade Name
- GLUCO-CARE FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- The GLUCO-CARE® HS100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effective-ness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The GLUCO-CARE® HS100 Blood Glucose Monitoring System is comprised of the GLUCO-CARE® HS100 Blood Glucose Meter and GLUCO-CARE® HS100 Blood Glucose Test Strip. FDA UDI
- Model / Reference
- HS100 FDA UDI
- Description
- The GLUCO-CARE® HS100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effective-ness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The GLUCO-CARE® HS100 Blood Glucose Monitoring System is comprised of the GLUCO-CARE® HS100 Blood Glucose Meter and GLUCO-CARE® HS100 Blood Glucose Test Strip. FDA UDI
Identifiers
- Catalog Number
- 4011 FDA UDI
- Primary DI / UDI-DI
- 00810008217498 FDA UDI
- 510(k) Number
- K182046 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-care
Gluco-Care by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182046 also covers:
- Genteel BT100 — LIGHT HILL MEDICAL CORPORATION
- Genteel BT100 — LIGHT HILL MEDICAL CORPORATION
- GLUCO-CARE — MediVena, LLC
- GLUCO-CARE — MediVena, LLC
- Tyson Bio HS100 Blood Glucose Meter — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Blood Glucose Monitoring System — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Blood Glucose Monitoring System — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Blood Glucose Monitoring System — TYSON BIORESEARCH INC.
- Tyson Bio HS100 Blood Glucose Monitoring System — TYSON BIORESEARCH INC.
- Tyson Bio HS100-B Blood Glucose Meter — TYSON BIORESEARCH INC.
- Tyson Bio HS100-B Blood Glucose Monitoring System — TYSON BIORESEARCH INC.
- Tyson Bio HS100-B Blood Glucose Monitoring System — TYSON BIORESEARCH INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MediVena, LLC
Sources (1)
- FDA UDI 8a7c1f49-8a16-4f9d-b6e6-c4b9f69cce49 37 fields · synced Jun 1, 2026