Smart Blood Pressure Monitor

GUDID 26947468535713

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID26947468535713
NIH Device Record Keyb3d39ff8-a949-4ab5-9953-4169b579d5cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Blood Pressure Monitor
Version Model NumberEOC-SBPBT-L(ePA-08B4)
Company DUNS529903321
Company NameShenzhen Belter Health Measurement and Analysis Technology 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 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
GS106947468535719 [Primary]
GS116947468535716 [Package]
Contains: 06947468535719
Package: 1pcs/box [1 Units]
In Commercial Distribution
GS126947468535713 [Package]
Contains: 16947468535716
Package: 20pcs/box [20 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 Number2
Public Version Date2019-11-08
Device Publish Date2018-07-28

Devices Manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

16947468500363 - RITE AID2023-09-28
16947468500356 - Bytech2023-07-04
16947468500349 - RITE AID2023-06-05
16947468500332 - NO2023-05-31
16947468500325 - Bluedot2023-04-06
16947468500318 - CARE TOUCH2022-11-22
16947468500295 - biotricity2022-08-26
16947468500301 - biotricity2022-08-26

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