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TidalPort Vascular Access Port

FDA UDI

Class II (US FDA UDI)

by Norfolk Medical

Identity

Trade Name
TidalPort Vascular Access Port FDA UDI
Generic Name
Infusion/injection port, implantable FDA UDI
Device Name
Standard Titanium TidalPort Vascular Access Port with 7F detached Polyurethane Catheter and Valved Introducer Kit FDA UDI
Model / Reference
TidalPort FDA UDI
Description
Standard Titanium TidalPort Vascular Access Port with 7F detached Polyurethane Catheter and Valved Introducer Kit FDA UDI

Identifiers

Catalog Number
SP31322KV FDA UDI
Primary DI / UDI-DI
M991SP31322KV1 FDA UDI
FDA Product Code
LJT FDA UDI
GMDN Term
Infusion/injection port, implantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5965 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

Yes

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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Total Volume — 0.53 Milliliter FDA UDI

Category: Infusion/injection port, implantable

TidalPort Vascular Access Port by Norfolk Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infusion/injection port, implantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Norfolk Medical

Sources (1)

  • FDA UDI 093d13f7-d3dc-4a61-b248-74eb0988d2aa 36 fields · synced Jun 8, 2026