FDA.reportPublic FDA data

ResQPOD ITD 16

Primary DI
00847946026943
Brand
ResQPOD ITD 16
Company
Zoll Medical Corporation
Model
12-0822-000
Device description
RESQPOD ITD 16, US
Published
2020-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PIZCombination compression/decompression manual chest pump with impedance respiratory valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIZCombination Compression/Decompression Manual Chest Pump With Impedance Respiratory ValveUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946026943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946026943008479460269438479460269430847946026943

GMDN Terms#

Term, Definition table
TermDefinition
Demand valveA non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-18 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure0 KiloPascal0
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
055363428
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00198843003675Infant Flow™777024-402026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847946026929RESQPOD ITD 10Zoll Medical CorporationPIZ2020-06-24
00847946026950ResQPUMP ACD-CPR DeviceZoll Medical CorporationPIZ2020-06-24
00847946026967ResQCPR SystemZoll Medical CorporationPIZ2020-06-24
00847946028282Suction Cup, ACD-CPR DeviceZoll Medical CorporationPIZ2020-06-24
00847946028305ResQPOD ITD 16Zoll Medical CorporationPIZ2020-06-24
00847946028312ResQPUMP InternationalZoll Medical CorporationPIZ2020-06-24
00847946028329ResQPOD ITD 10, MilitaryZoll Medical CorporationPIZ2020-06-24
M5921208250001ResQCPR SystemADVANCED CIRCULATORY SYSTEMS INCPIZ2016-01-19