Identity
- Trade Name
- BREEZE® 2 FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- Control Solution - Normal, 1 x 2.5 mL FDA UDI
- Model / Reference
- 1489A FDA UDI
- Description
- Control Solution - Normal, 1 x 2.5 mL FDA UDI
Identifiers
- Catalog Number
- 81007188 FDA UDI
- Primary DI / UDI-DI
- 10301931489016 FDA UDI
- FDA Product Code
- JJX FDA UDINBW FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI862.1345 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
Breeze® 2 by Ascensia Diabetes Care Us Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Ascensia Diabetes Care Us Inc.
Sources (1)
- FDA UDI a01eae00-4bd9-43e7-87f8-b4da6afa5153 37 fields · synced Jun 8, 2026