FDA.reportPublic FDA data

Ventilator

Primary DI
00847946024130
Brand
Ventilator
Company
Zoll Medical Corporation
Model
703-0904-16
Device description
CLAMP WITH DOVETAIL,CCLAW
Published
2018-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162832000731 Series VentilatorsZOLL Medical Corporation2017-08-02CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946024130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946024130008479460241308479460241300847946024130

GMDN Terms#

Term, Definition table
TermDefinition
Transport electric ventilatorAn electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

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
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847946029500X SERIES630-2271211-012020-09-29
00847946050740ZENIX1116-111075-21-USA-02026-09-25
00198843006454LTV18888-201-012026-09-18
00198843006492LTV18888-001-012026-09-18
00198843006515LTV18978-001-012026-09-18
00198843006539LTV18246-004-012026-09-18
00198843007352LTV18246-201-012026-09-18
001988430062703100B HFOV11744-850K-402026-08-26
001988430062943100A HFOV29028-003-402026-08-26
001988430063003100A HFOV29028-004-402026-08-26
001988430063243100B HFOV29028-016-402026-08-26
001988430063623100 HFOV11437-PMN-402026-08-26
00847946030926ZENIX8900-000421-012026-08-26
00198843003606Infant Flow™777010-402026-08-14
00198843003613Infant Flow™777012-402026-08-14
00198843003620Infant Flow™777014-402026-08-14
00198843003637Infant Flow™777016-402026-08-14
00198843003644Infant Flow™777018-402026-08-14
00198843003651Infant Flow™777020-402026-08-14
00198843003668Infant Flow™777022-402026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
00840178704955ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704962ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704979ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704986ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704993ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705006ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705013ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705020ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705037ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705044ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705051ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705068ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705075ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705082ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705099ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705105ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705112ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705129ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705136ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705143ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705150ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705167ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705174ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705181ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705198ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705204ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705211ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705235ITDTouchpoint Medical, Inc.BZN2026-10-15