Patient leads, ECG cable

GUDID 10840935107798

SUNTECH MEDICAL, INC.

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID10840935107798
NIH Device Record Key3f66251d-ca05-44bc-842d-d9005bd8b6d3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient leads, ECG cable
Version Model Number91-0004-00
Company DUNS148191133
Company NameSUNTECH MEDICAL, INC.
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-919-654-2300
EmailUDI_MAIL@suntechmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110840935107798 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2018-01-03

Devices Manufactured by SUNTECH MEDICAL, INC.

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10840935110217 - ProLife2023-06-19
10840935110224 - SunTech APC2023-06-19
10840935110231 - ProLife2023-06-19
10840935110248 - ProLife2023-06-19
10840935110255 - ProLife2023-06-19
10840935110262 - ProLife2023-06-19
10840935110279 - SunTech APC2023-06-19

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