Identity
- Trade Name
- On Call Express Blood Glucose Monitor FDA UDI
- Generic Name
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
- Device Name
- Blood Glucose Meter FDA UDI
- Model / Reference
- G115-11D FDA UDI
- Description
- Blood Glucose Meter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00024291121824 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
On Call Express Blood Glucose Monitor by Navajo Manufacturing Company Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Navajo Manufacturing Company Inc.
Sources (1)
- FDA UDI 532b8c3c-0abe-4a37-87c6-0955b9d994ea 35 fields · synced Jun 6, 2026