FDA.report

Pursuant Health Station

Primary DI
00865878000305
Brand
Pursuant Health Station
Company
SOLOHEALTH, INC.
Model
G1.D3
Published
2017-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00865878000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00865878000305008658780003058658780003050865878000305

GMDN Terms

TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.

Sterilization Methods

Method

Regulatory Flags

DUNS number
828333646
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00865878000312Pursuant Health StationG1.D42017-11-03

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