Identity
- Trade Name
- TeleRPM & Chronica FDA UDI
- Generic Name
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
- Device Name
- TeleRPM Blood Glucose Monitoring System FDA UDI
- Model / Reference
- TMB-2282-G FDA UDI
- Description
- TeleRPM Blood Glucose Monitoring System FDA UDI
Identifiers
- Catalog Number
- TMB-2282-G FDA UDI
- Primary DI / UDI-DI
- 00850042929247 FDA UDI
- GMDN Term
- Blood glucose/blood pressure monitoring system, home-use FDA UDI
Classification
- 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood lancet, single-useGlucose IVD, kit, electrometryManual blood lancing device, reusableBlood glucose/blood pressure monitoring system, home-use
TeleRPM & Chronica by Mio Labs Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Mio Labs Inc.
Sources (1)
- FDA UDI 29bf2547-6b0b-4f1f-aa6c-9e685a8d548e 34 fields · synced May 30, 2026