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Heartrail

FDA UDI

Class II (US FDA UDI)

by Terumo Corp.

Identity

Trade Name
HEARTRAIL FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
HEARTRAIL III Guiding Catheter FDA UDI
Model / Reference
40-5357 FDA UDI
Description
HEARTRAIL III Guiding Catheter FDA UDI

Identifiers

Catalog Number
GC-U5MP030N FDA UDI
Primary DI / UDI-DI
04987350866332 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

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

Dimensions & Sizes

Size
Length — 100 Centimeter FDA UDI
Lumen/Inner Diameter — 1.47 Millimeter FDA UDI
Pressure — 4826 KiloPascal FDA UDI
Outer Diameter — 1.75 Millimeter FDA UDI

Category: Vascular guide-catheter, single-use

Heartrail by Terumo Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Terumo Corp.

Sources (1)

  • FDA UDI f17196aa-81ec-44b1-bd6c-1c2b3fc01695 37 fields · synced Jun 8, 2026