Ventilator

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name: VENTILATOR FDA UDI
Generic Name: Transport electric ventilator FDA UDI
Device Name: MAIN ASSEMBLY, VENTILATOR, COMMERCIAL STANDARD, ZVENT 4TH EDITION FDA UDI
Model / Reference: 1660-001401-01 FDA UDI
Description: MAIN ASSEMBLY, VENTILATOR, COMMERCIAL STANDARD, ZVENT 4TH EDITION FDA UDI

Identifiers

Primary DI / UDI-DI: 00847946050344 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Transport electric ventilator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Transport electric ventilator

Ventilator by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transport electric ventilator.

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Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Pneupac — ICU MEDICAL, INC. · Class II
Life Support Products — Allied Medical LLC · Class II
Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
Continuous Ventilator — FLIGHT MEDICAL INNOVATIONS LTD · 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

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Manufacturer

Manufacturer: Zoll Medical Corporation

Sources (1)

FDA UDI 48363fcf-ac98-4b05-87e1-7d5e69f0f074 34 fields · synced Jun 8, 2026