Identity
- Trade Name
- Accu-Chek Combo FDA UDI
- Generic Name
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
- Device Name
- Accu-Chek Spirit Combo FDA UDI
- Model / Reference
- 05027250001 FDA UDI
- Description
- Accu-Chek Spirit Combo FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04015630880119 FDA UDI
- FDA Product Code
- LZG FDA UDI
- GMDN Term
- Ambulatory insulin infusion pump/blood glucose analyser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
No
FDA UDI
Accu-Chek Combo by Roche Diabetes Care, 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
- Roche Diabetes Care, Inc.
Sources (1)
- FDA UDI 4a328b24-223c-411b-93cd-9047ff15b125 34 fields · synced Jun 1, 2026