Ventilator

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name: VENTILATOR FDA UDI
Generic Name: Ventilator breathing circuit, single-use FDA UDI
Device Name: KIT, ACCESSORIES, EMV+, MILITARY,W/ MASIMO, BERRY COMPLIANT FDA UDI
Model / Reference: 499-0002-01-30 FDA UDI
Description: KIT, ACCESSORIES, EMV+, MILITARY,W/ MASIMO, BERRY COMPLIANT FDA UDI

Identifiers

Primary DI / UDI-DI: 00847946092863 FDA UDI
FDA Product Code: CBK FDA UDI
DQA FDA UDI
GMDN Term: Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
870.2700 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

Category: Ventilator breathing circuit, single-use

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

Similar devices

Also classified as Ventilator breathing circuit, single-use.

HUDSON RCI — TELEFLEX INCORPORATED · Class II
MEDIFLEX — Mediflex Medikal · Class IIa
ALTECH — Meditera Tıbbi Malzeme Sanayi ve Ticaret A.Ş. · Class IIa
Infant Resuscitation Kit. T-Piece Circuit — FLEXICARE MEDICAL LIMITED · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class II
AirLife™ — Airlife, Inc. · Class II
Classic RT — Plastiflex Group NV · Class I

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: Zoll Medical Corporation

Sources (1)

FDA UDI 7a0c4ea6-4833-43a6-91a3-90e9d94bb34c 34 fields · synced Jun 8, 2026