Identity
- Trade Name
- OneTouch Ultra FDA UDI
- Generic Name
- Glucose monitoring system IVD, point-of-care FDA UDI
- Device Name
- One Touch Ultra Control Solution FDA UDI
- Model / Reference
- 021-416 FDA UDI
- Description
- One Touch Ultra Control Solution FDA UDI
Identifiers
- Catalog Number
- 021-416 FDA UDI
- Primary DI / UDI-DI
- 00353885006231 FDA UDI
- 510(k) Number
- K103553 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose monitoring system IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- 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
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
Yes
FDA UDI
Category: Glucose monitoring system IVD, point-of-care
OneTouch Ultra by Lifescan Europe — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103553 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lifescan Europe
Sources (1)
- FDA UDI 1bd4c6a5-b0d8-4939-b9b1-a68945194379 36 fields · synced Jun 8, 2026