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Hamilton-Bc4022

FDA UDI

Class II (US FDA UDI)

by Hamilton Medical, Inc.

Identity

Trade Name
HAMILTON-BC4022 FDA UDI
Generic Name
Ventilator breathing circuit, single-use FDA UDI
Device Name
HAMILTON-BC4022, breathing circuit set, single limb, heated, with water chamber FDA UDI
Model / Reference
260186 FDA UDI
Description
HAMILTON-BC4022, breathing circuit set, single limb, heated, with water chamber FDA UDI

Identifiers

Catalog Number
260186 FDA UDI
Primary DI / UDI-DI
07630002804189 FDA UDI
510(k) Number
K152029 FDA UDI
FDA Product Code
BZE FDA UDI
GMDN Term
Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5270 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ventilator breathing circuit, single-useInspiratory line humidification chamber, single-use

Hamilton-Bc4022 by Hamilton Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inspiratory line humidification chamber, single-use.

Cleared under the same submission

K152029 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hamilton Medical, Inc.

Sources (1)

  • FDA UDI 220b3b2b-33e6-40d2-9407-f8d1058ccf61 36 fields · synced May 31, 2026