IntelliCuff

FDA UDI

Class II (US FDA UDI)

by Hamilton Medical, Inc.

Identity

Trade Name: IntelliCuff FDA UDI
Generic Name: Endotracheal tube cuff inflator FDA UDI
Model / Reference: 951001 FDA UDI

Identifiers

Catalog Number: 951001 FDA UDI
Primary DI / UDI-DI: 07630002800839 FDA UDI
510(k) Number: K150893 FDA UDI
FDA Product Code: BSK FDA UDI
GMDN Term: Endotracheal tube cuff inflator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5750 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Endotracheal tube cuff inflator

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

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AG Cuffill Kruuse - VET — HOSPITECH RESPIRATION LTD · Class II
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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: Hamilton Medical, Inc.

Sources (1)

FDA UDI b3323140-743c-4d7d-b248-4a67135630cf 34 fields · synced May 30, 2026