Identity
- Trade Name
- I-port Advance FDA UDI
- Generic Name
- Subcutaneous infusion/injection port needle FDA UDI
- Device Name
- Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use. FDA UDI
- Model / Reference
- MMT-100 FDA UDI
- Description
- Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05705244009394 FDA UDI
- FDA Product Code
- FOZ FDA UDI
- GMDN Term
- Subcutaneous infusion/injection port needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Depth — 6 Millimeter FDA UDIAngle — 90 degree FDA UDI
I-port Advance by Unomedical A/S — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unomedical A/S
Sources (1)
- FDA UDI 28646963-e29d-481f-8ed8-7e309d1aa0cb 37 fields · synced Jun 8, 2026