Hamilton-H900

FDA UDI

Class II (US FDA UDI)

by Hamilton Medical, Inc.

Identity

Trade Name: HAMILTON-H900 FDA UDI
Generic Name: Heated respiratory humidifier FDA UDI
Model / Reference: 950004 FDA UDI

Identifiers

Catalog Number: 950004 FDA UDI
Primary DI / UDI-DI: 07630002801546 FDA UDI
FDA Product Code: BTT FDA UDI
GMDN Term: Heated respiratory humidifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5450 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: Heated respiratory humidifier

Hamilton-H900 by Hamilton Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Heated respiratory humidifier.

Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
A Series Heated Humidifier — Respironics, Inc. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hamilton Medical, Inc.

Sources (1)

FDA UDI 5f7c64c9-b9f0-436d-bea2-265d49cf2187 33 fields · synced Jun 8, 2026