Identity
- Trade Name
- ODM FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573). FDA UDI
- Model / Reference
- iGlucose Blood Glucose Monitoring System FDA UDI
- Description
- The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573). FDA UDI
Identifiers
- Catalog Number
- 99GM291I01 FDA UDI
- Primary DI / UDI-DI
- 00883489001504 FDA UDI
- 510(k) Number
- K161790 FDA UDI
- FDA Product Code
- NBW FDA UDICGA 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
Yes
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
Yes
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
Category: Glucose monitoring system IVD, home-use
Odm by Bionime Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose monitoring system IVD, home-use.
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Cleared under the same submission
K161790 also covers:
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
- Bionime Corporation
Sources (1)
- FDA UDI 24bd8864-462f-451d-80ea-dc478ffab99e 37 fields · synced May 30, 2026