FDA.reportPublic FDA data

ResQPOD ITD 10, Military

Primary DI
00847946028329
Brand
ResQPOD ITD 10, Military
Company
Zoll Medical Corporation
Model
12-0242-030
Device description
RESQPOD ITD 10, MILITARY
Published
2020-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BWFSPIROMETER, THERAPEUTIC (INCENTIVE)
PIZCombination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2
PIZCombination Compression/Decompression Manual Chest Pump With Impedance Respiratory ValveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033401000MODIFICATION TO RESQPOD CIRCULATORY ENHANCERAdvanced Circulatory Systems, Inc.2003-11-20BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847946028329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847946028329008479460283298479460283290847946028329

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
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
10847946021334Cuffs9355-16412016-09-16
10847946021341Cuffs9355-16422016-09-16
10847946021358Cuffs9355-16432016-09-16
10847946021365Cuffs9355-16442016-09-16
00847946023058ACCUVENT9500-0006632022-11-01
10847946023130PATIENT CIRCUITS812-0008-202022-06-08
10847946023123PATIENT CIRCUITS812-0007-202015-10-28
10847946023147PATIENT CIRCUITS812-0009-202015-10-28
10847946023154PATIENT CIRCUITS812-0010-202015-10-28
10847946023161PATIENT CIRCUITS812-0011-202015-10-28
10847946023215PATIENT CIRCUITS712-0002-202020-10-22
00847946026929RESQPOD ITD 1012-0242-0002020-06-24
20847946023137PATIENT CIRCUITS812-0008-402015-10-28
20847946023182PATIENT CIRCUITS812-0007-402015-10-28
00847946016746ZOLL CABLE1009-0918-012014-09-24
00847946016760ZOLL CABLE1009-0913-022014-09-23

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