Identity
- Trade Name
- Genteel BT100 FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Genteel Blood Glucose Meter FDA UDI
- Model / Reference
- BT-100M FDA UDI
- Description
- Genteel Blood Glucose Meter FDA UDI
Identifiers
- Catalog Number
- BT-100M FDA UDI
- Primary DI / UDI-DI
- 00860013530204 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glucose monitoring system IVD, home-use
Genteel BT100 by Light Hill Medical Corporation — 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
- GLUCO-CARE — MediVena, LLC
- 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
- Light Hill Medical Corporation
Sources (1)
- FDA UDI db8b279a-554a-4977-b1d0-53ac247dc7cd 36 fields · synced Jun 1, 2026