FDA.reportPublic FDA data

Electronic Blood Pressure Monitor

Primary DI
06948423800149
Brand
Electronic Blood Pressure Monitor
Company
Shenzhen Pango Electronic Co., Ltd.
Model
PG-800B8
Published
2016-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K131558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131558000PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6Shenzhen Pango Electronic Co., Ltd.2013-08-30DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948423800347PackageGS11In Commercial Distribution
06948423800149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948423800347069484238003476948423800347
06948423800149069484238001496948423800149

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529222127
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948423808763Infrared ThermometerPG-IRT16032020-04-17
06948423808817Infrared ThermometerPG-IRT16012020-04-17
06948423808824Infrared ThermometerPG-IRT16022020-04-17
06948423800002Electronic Blood Pressure MonitorPG-800B2016-11-23
06948423800019Electronic Blood Pressure MonitorPG-800BD2016-11-23
06948423800026Electronic Blood Pressure MonitorPG-800B-12016-11-23
06948423800033Electronic Blood Pressure MonitorPG-800BD-12016-11-23
06948423800040Electronic Blood Pressure MonitorPG-800B32016-11-23
06948423800057Electronic Blood Pressure MonitorPG-800B42016-11-23
06948423800064Electronic Blood Pressure MonitorPG-800B4D2016-11-23
06948423800071Electronic Blood Pressure MonitorPG-800B52016-11-23
06948423800088Electronic Blood Pressure MonitorPG-800B5-12016-11-23
06948423800095Electronic Blood Pressure MonitorPG-800B62016-11-23
06948423800101Electronic Blood Pressure MonitorPG-800B6D2016-11-23
06948423800118Electronic Blood Pressure MonitorPG-800B6-12016-11-23
06948423800125Electronic Blood Pressure MonitorPG-800B6-22016-11-23
06948423800132Electronic Blood Pressure MonitorPG-800B72016-11-23
06948423800156Electronic Blood Pressure MonitorPG-800B92016-11-23
06948423800163Electronic Blood Pressure MonitorPG-800B102016-11-23
06948423800170Electronic Blood Pressure MonitorPG-800B112016-11-23

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Primary DI, Brand, Company table
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