BOTHEALTH

GUDID 06920485305169

Shenzhen BSX Technology Electronics Co., Ltd.

Patient monitoring system module, blood pressure, noninvasive
Primary Device ID06920485305169
NIH Device Record Key9df8aa28-6000-45ac-b63a-ce8ce89763a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBOTHEALTH
Version Model NumberBSX516
Company DUNS551105453
Company NameShenzhen BSX Technology Electronics 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS106920485305169 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-27
Device Publish Date2019-09-19

On-Brand Devices [BOTHEALTH]

06920485305831BSX583
06920485305251BSX525
06920485305169BSX516
06920485305954BSX595
06920485305930BSX593
06920485305237BSX523
06920485305879BSX587
06920485305794BSX579
06920485305787BSX578
06920485305725BSX572
06920485305688BSX568
06920485305633BSX563
06920485305619BSX561
06920485305589BSX558
06920485305565BSX556
06920485305534BSX553
06920485305381BSX538
06920485305268BSX526
06920485305190BSX519
06920485305152BSX515
06920485305138BSX513
06920485305084BSX508
06920485305053BSX505
06920485305015BSX501

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