Identity
- Trade Name
- Insulia FDA UDI
- Generic Name
- Home pharmaceutical management support software FDA UDI
- Model / Reference
- Redwing W_1.6_US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760261310061 FDA UDI
- 510(k) Number
- K172177 FDA UDI
- FDA Product Code
- NDC FDA UDI
- GMDN Term
- Home pharmaceutical management support software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Home pharmaceutical management support software
Insulia by Voluntis Sa. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home pharmaceutical management support software.
- Health Optimizer — WELLDOC · Class II
- Conifer Connect Diabetes — WELLDOC · Class II
- Conifer Connect Diabetes Rx — WELLDOC · Class II
- OneTouch Reveal Plus — WELLDOC · Class II
- BlueStar — WELLDOC · Class II
- Tempo Insights — WELLDOC
- ByramConnect Rx — WELLDOC · Class II
- Bluestar — WELLDOC · Class II
Cleared under the same submission
K172177 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Voluntis Sa.
Sources (1)
- FDA UDI 1384c710-9146-4adf-80b9-88f5b406b4af 33 fields · synced Jun 1, 2026