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Portex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Portex FDA UDI
Generic Name
Epidural anaesthesia set, non-medicated FDA UDI
Model / Reference
A1976-17 FDA UDI

Identifiers

Primary DI / UDI-DI
20351688038453 FDA UDI
510(k) Number
K965017 FDA UDI
FDA Product Code
CAZ FDA UDI
GMDN Term
Epidural anaesthesia set, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5140 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

Category: Epidural anaesthesia set, non-medicated

Portex by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epidural anaesthesia set, non-medicated.

Cleared under the same submission

K965017 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI a49b0e49-7a6c-47db-88ea-62c02b900bb4 33 fields · synced May 31, 2026