Electronic Blood Pressure Monitor

GUDID 06948423800071

Shenzhen Pango Electronic Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID06948423800071
NIH Device Record Key13ae587f-a0a7-4e0b-b434-e865ad67390a
Commercial Distribution StatusIn Commercial Distribution
Brand NameElectronic Blood Pressure Monitor
Version Model NumberPG-800B5
Company DUNS529222127
Company NameShenzhen Pango Electronic Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106948423800071 [Primary]
GS106948423800279 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-11-23

On-Brand Devices [Electronic Blood Pressure Monitor]

06948423807520PG-800B43
06948423807513PG-800B42
06948423806769PG-800B23
06948423806424PG-800B27
06948423806417PG-800B37
06948423806400PG-800B36
06948423806394PG-800B26
06948423806387PG-800A37
06948423806059PG-800A36
06948423806042PG-800B35
06948423806035PG-800B32
06948423806028PG-800A35
06948423806011PG-800A33
06948423806004PG-800A32
06948423805830PG-800B22
06948423805632PG-800B33
06948423805281PG-800A31
06948423804598PG-800B31
06948423802792PG-800A27
06948423802778PG-800A25
06948423800583PG-800A15
06948423800576PG-800A12
06948423800569PG-800A11
06948423800552PG-800A9
06948423800545PG-800A8
06948423800538PG-800A7D
06948423800521PG-800A7
06948423800514PG-800A6-2
06948423800507PG-800A6-1
06948423800491PG-800A6D
06948423800484PG-800A6
06948423800477PG-800A5
06948423800460PG-800A4D
06948423800453PG-800A4
06948423800446PG-800A3
06948423800439PG-800AD-1
06948423800422PG-800A-1
06948423800415PG-800AD
06948423800408PG-800A
06948423800194PG-800B15
06948423800187PG-800B12
06948423800170PG-800B11
06948423800163PG-800B10
06948423800156PG-800B9
06948423800149PG-800B8
06948423800132PG-800B7
06948423800125PG-800B6-2
06948423800118PG-800B6-1
06948423800101PG-800B6D
06948423800095PG-800B6

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