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Intran

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref IUP-450

by Utah Medical Products, Inc.

Identity

Trade Name
INTRAN EUDAMEDFDA UDI
Generic Name
Intrapartum pressure monitoring catheter FDA UDI
Device Name
Intran EUDAMED
Disposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Disposable Catheter, Small Size Tip FDA UDI
Model / Reference
IUP-450 EUDAMED
Plus FDA UDI
Description
Disposable Intrauterine Pressure Catheter System with Amnioinfusion Capability, Zeroing Switch in Disposable Catheter, Small Size Tip FDA UDI

Identifiers

Catalog Number
IUP-450 FDA UDI
Primary DI / UDI-DI
H671IUP4500 EUDAMEDFDA UDI
Basic UDI-DI
++H671CE005IIACE EUDAMED
FDA Product Code
HFN FDA UDI
KXO FDA UDI
EMDN Code
U100199 OBSTETRICAL CATHETERS - OTHER EUDAMED
GMDN Term
Intrapartum pressure monitoring catheter FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
884.2700 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Intran by Utah Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Utah Medical Products, Inc.

Sources (2)

  • FDA UDI 87675444-fca9-4eb7-a4d0-587f7d85f40c 36 fields · synced Oct 7, 2026
  • EUDAMED 1604ca14-abcb-43b1-ab1f-fa4b9ef2ee41 61 fields · synced Aug 2, 2026