FDA.reportPublic FDA data

Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries

Primary DI
05060488570926
Brand
Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
002-102738
Catalog number
002-102738
Device description
Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries
Published
2020-01-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150545000Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)Sejoy Electronics & Instruments Co., Ltd.2015-04-02DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488571008PackageGS124In Commercial Distribution
05060488570926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488571008050604885710085060488571008
05060488570926050604885709265060488570926

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-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 designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Inch
Length6Inch
Width12Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 855 237 7622sales@proactivemedical.com

Regulatory Flags#

DUNS number
078582655
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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05060488573316Protekt PartsPP-AHFAASMK3LFTPP-AHFAASMK3LFT2022-11-18
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05060488570186Protekt Aire94004940042016-08-12
05060488570452Protekt Aire Replacement Pump80091800912016-08-12
05060488570490Protekt Aire Replacement Mattress80032800322016-08-12
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05060488570544Protekt Aire Replacement Mattress80082800822016-08-12
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05060488570728Protekt Aire83500835002018-03-07
05060488570735Protekt Aire83600836002018-03-07
05060488570742Protekt Aire84600846002018-03-07
05060488570773Protekt Aire81090-42B81090-42B2018-03-07
05060488570780Protekt Aire81090-48B81090-48B2018-03-07

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Primary DI, Brand, Company table
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