Identity
- Trade Name
- Onset FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- Onset Cartridge Connector FDA UDI
- Model / Reference
- 40045 FDA UDI
- Description
- Onset Cartridge Connector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001977301 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Onset by Onpharma Company — 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
- Onpharma Company
Sources (1)
- FDA UDI b78f36cd-b15a-47b7-b7fc-4ce7b18e7f80 35 fields · synced May 29, 2026