Reusable Airway Adapter

FDA UDI

Class II (US FDA UDI)

by Zoll Medical Corporation

Identity

Trade Name: REUSABLE AIRWAY ADAPTER FDA UDI
Generic Name: Physiologic-monitoring defibrillation system FDA UDI
Device Name: ADULT REUSABLE AIRWAY ADAPTER FDA UDI
Model / Reference: 9355-0302 FDA UDI
Description: ADULT REUSABLE AIRWAY ADAPTER FDA UDI

Identifiers

Primary DI / UDI-DI: 00847946024048 FDA UDI
510(k) Number: K120907 FDA UDI
FDA Product Code: DQA FDA UDI
DRO FDA UDI
CCK FDA UDI
DXN FDA UDI
DRM FDA UDI
MKJ FDA UDI
DRT FDA UDI
LDD FDA UDI
GMDN Term: Physiologic-monitoring defibrillation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
870.5550 FDA UDI
868.1400 FDA UDI
870.1130 FDA UDI
870.5200 FDA UDI
870.5310 FDA UDI
870.2300 FDA UDI
870.5300 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Physiologic-monitoring defibrillation system

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

Similar devices

Also classified as Physiologic-monitoring defibrillation system.

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LIFEPAK 35 Monitor/Defibrillator — PHYSIO-CONTROL, Inc. · Class III
LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
RELI LIFEPAK 20E — PHYSIO-CONTROL, Inc. · Class III
LIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, Inc. · Class III
LIFEPAK 20 and LIFEPAK 20e defibrillator/monitors — PHYSIO-CONTROL, Inc. · Class III

Cleared under the same submission

K120907 also covers:

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 618ef019-35c4-40b6-bfa5-9b3281334388 35 fields · synced Jun 8, 2026