Identity
- Trade Name
- Rosie SmartMeter FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- Rosie SmartMeter Blood Glucose Monitoring System FDA UDI
- Model / Reference
- AC11 FDA UDI
- Description
- Rosie SmartMeter Blood Glucose Monitoring System FDA UDI
Identifiers
- Catalog Number
- 3K-01-16003H FDA UDI
- Primary DI / UDI-DI
- 00389154000389 FDA UDI
- 510(k) Number
- K113307 FDA UDI
- FDA Product Code
- LFR FDA UDIJJX FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1660 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rosie SmartMeter by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K113307 also covers:
- GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) — Hmd Biomedical, LLC
- GL GoodLife AC-302 Blood Glucose Monitoring System, Economy type(CORP.) — Hmd Biomedical, LLC
- GL GoodLife AC11-Strip(foil) — Hmd Biomedical, LLC
- GL GoodLife Blood Glucose Test Strip(CORP.) — Hmd Biomedical, LLC
- GoodLife foil packed test strip — Hmd Biomedical, LLC
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
- Hmd Biomedical, LLC
Sources (1)
- FDA UDI 0211a33d-e25a-4a88-aa92-7fb6e8440938 38 fields · synced Jun 1, 2026