I-port Advance

FDA UDI

Class II (US FDA UDI)

by Unomedical A/S

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-101T 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: 05705244014183 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Angle — 90 degree FDA UDI
Depth — 9 Millimeter FDA UDI

Category: Subcutaneous infusion/injection port needle

I-port Advance by Unomedical A/S — 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: Unomedical A/S

Sources (1)

FDA UDI a24c468a-adcc-44b9-a51f-2fab924f64c2 36 fields · synced Jun 8, 2026