FDA.reportPublic FDA data

REUSABLE AIRWAY ADAPTER

Primary DI
00847946024048
Brand
REUSABLE AIRWAY ADAPTER
Company
Zoll Medical Corporation
Model
9355-0302
Device description
ADULT REUSABLE AIRWAY ADAPTER
Published
2021-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
DQAOximeter
DRMCompressor, cardiac, external
DROPACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DXNSystem, measurement, blood-pressure, non-invasive
LDDDc-defibrillator, low-energy, (including paddles)
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
DQAOximeterCardiovascular2
DRMCompressor, Cardiac, ExternalCardiovascular2
DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)Cardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120907000ZOLL R SERIESZoll Medical Corporation, World Wide Headquarters2012-09-25MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946024048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946024048008479460240488479460240480847946024048

GMDN Terms#

Term, Definition table
TermDefinition
Physiologic-monitoring defibrillation systemAn assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius0 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius0 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198843002852bellavista301.115.010-012026-07-10
00198843002869bellavista301.115.020-012026-07-10
00198843002876bellavista302.396.000-402026-07-06
00198843001145bellavista301.328.020-402026-06-24
00198843001152bellavista301.470.020-402026-06-24
00198843003347Infant Flow™777000XS-402026-06-24
00198843003361Infant Flow™777000S-402026-06-24
00198843003385Infant Flow™777000M-402026-06-24
00198843003408Infant Flow™777000L-402026-06-24
00198843003422Infant Flow™777000XL-402026-06-24
00198843003545Infant Flow™777040XS-402026-06-24
00198843003552Infant Flow™777040S-402026-06-24
00198843003569Infant Flow™777040SM-402026-06-24
00198843003576Infant Flow™777040M-402026-06-24
00198843003583Infant Flow™777040L-402026-06-24
00198843003590Infant Flow™777040XL-402026-06-24
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004040-012026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODE8900-004041-012026-05-29
00847946021986HWD Electrode Set9610-000181-012016-10-20
10847946021327Cuffs9355-16402016-09-16

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Primary DI, Brand, Company table
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04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
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06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
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