Identity
- Trade Name
- iHealth FDA UDI
- Generic Name
- Glucose analyser IVD, home-use FDA UDI
- Model / Reference
- BG5SKIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850044118236 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Glucose analyser 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose analyser IVD, home-use
iHealth by Ihealth Lab Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose analyser IVD, home-use.
- Accu-Chek Guide — Roche Diagnostics Operations, Inc. · Class II
- MIO / TeleRPM — Mio Labs Inc. · Class II
- CURO L5 — KPI HEALTHCARE, INC. · Class II
- OneTouch Verio Flex — Lifescan Europe · Class II
- telli health — Bioland Technology Ltd. · Class II
- OneTouch Ultra2 — Lifescan Europe · Class II
- NuvoMed — NUVOMED INC · Class II
- VivaGuard Ino Smart Blood Glucose Meter — ABOUND Diagnostics, Inc · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ihealth Lab Inc.
Sources (1)
- FDA UDI d871907a-0f05-422f-8450-9e92ea74e0b9 32 fields · synced Jun 8, 2026