Identity
- Trade Name
- On-body Infusor for Furoscix® FDA UDI
- Generic Name
- Ambulatory non-insulin infusion pump, electronic FDA UDI
- Device Name
- A wearable, single-use, electromechanical (battery powered, micro-processor controlled), on-body delivery system that is pre-programmed to deliver 80 mg of FUROSCIX over 5-hours using a bi-phasic delivery profile. FDA UDI
- Model / Reference
- DWG-0189 FDA UDI
- Description
- A wearable, single-use, electromechanical (battery powered, micro-processor controlled), on-body delivery system that is pre-programmed to deliver 80 mg of FUROSCIX over 5-hours using a bi-phasic delivery profile. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00371767000009 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Ambulatory non-insulin infusion pump, electronic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 116 Millimeter FDA UDIWidth — 61 Millimeter FDA UDIHeight — 30 Millimeter FDA UDI
Category: Ambulatory non-insulin infusion pump, electronic
On-body Infusor for Furoscix® by Scpharmaceuticals Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Scpharmaceuticals Inc.
Sources (1)
- FDA UDI 09c7ff39-9242-4904-b30b-53edc3fc08e3 36 fields · synced May 30, 2026