FDA.reportPublic FDA data

GoWISE USA

Primary DI
00819687020115
Brand
GoWISE USA
Company
MING'S MARK INC.
Model
GW22063
Published
2017-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
OEDAntimicrobial Blood Pressure Cuff
OFECentral Venous Blood Pressure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEDAntimicrobial Blood Pressure CuffCardiovascular2
OFECentral Venous Blood Pressure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819687020112PackageGS11In Commercial Distribution
20819687020119PackageGS118In Commercial Distribution
00819687020115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081968702011210819687020112
2081968702011920819687020119
00819687020115008196870201158196870201150819687020115

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.

Regulatory Flags#

DUNS number
005175432
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853821006030GoWISE USAGW220292016-08-23
00819687020290GoWISE USA GW220412017-12-29
00819687020306GoWISE USA GW220422017-12-29
00853113007028GoWISE USA GW220512016-12-06
00853821006368GoWISE USA GW220402017-03-12
20853113007022GoWISE USA GW220512016-12-06
00853821006023GoWISE USAGW220252016-08-23
00853821006047GoWISE USAGW220272016-08-23
20853821006362GoWISE USA GW220402017-03-12
00853821006825GoWISE USAGW220612016-08-23
20819687020119GoWISE USA GW220632017-07-26
20819687020294GoWISE USA GW220412017-12-29
20819687020300GoWISE USA GW220422017-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956133433CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
10198956133716CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
50198956133431CARDINAL HEALTHCardinal Health 200, LLCOFE2025-07-10
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10198956114296CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-24
10198956070653CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-06
50198956070651CARDINAL HEALTHCardinal Health 200, LLCOFE2025-06-06
10198956074347CARDINAL HEALTHCardinal Health 200, LLCOFE2025-05-15
50198956074345CARDINAL HEALTHCardinal Health 200, LLCOFE2025-05-15
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20884838114863NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
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00884838114869NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-04-01
10198956019737CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-25
50198956019735CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-25
20884838114825NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114832NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114849NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
20884838114856NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
00884838114722NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-23
10198956002685CARDINAL HEALTHCardinal Health 200, LLCOFE2025-03-21
20884838114818NIBP CuffsPhilips Medizin Systeme Böblingen GmbHOED2025-03-14
10197106714690CARDINAL HEALTHCardinal Health 200, LLCOFE2024-07-08
10197106651339CARDINAL HEALTHCardinal Health 200, LLCOFE2024-04-29
10197106596593CARDINAL HEALTHCardinal Health 200, LLCOFE2024-03-08