Console Standoff

FDA UDI

Class II (US FDA UDI)

by Thoratec Switzerland GmbH

Identity

Trade Name: CONSOLE STANDOFF FDA UDI
Generic Name: Portable active medical device mount FDA UDI
Model / Reference: 104305 FDA UDI

Identifiers

Catalog Number: 104305 FDA UDI
Primary DI / UDI-DI: 07640135140320 FDA UDI
FDA Product Code: KFM FDA UDI
GMDN Term: Portable active medical device mount FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Portable active medical device mount

Console Standoff by Thoratec Switzerland GmbH — 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: Thoratec Switzerland GmbH

Sources (1)

FDA UDI 91ee0347-5130-44ff-90bf-e9905d4102a1 35 fields · synced May 30, 2026