FDA.report

Pursuant Health Kiosk

Primary DI
00865878000343
Brand
Pursuant Health Kiosk
Company
Pursuant Health, Inc.
Model
G1.D3S
Published
2023-01-04
Public version status
New
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
00865878000343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00865878000343008658780003438658780003430865878000343

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
true
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
00865878000350Pursuant Health KioskG1.D52024-01-11
00865878000329Pursuant Health KioskG1.D12023-01-04
00865878000336Pursuant Health KioskG1.D22023-01-04

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