Cable, Sp02, LPXpod, 2m

GUDID 10840935107804

SUNTECH MEDICAL, INC.

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID10840935107804
NIH Device Record Key25d00837-0528-49fc-89ed-603ab9bb3b4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCable, Sp02, LPXpod, 2m
Version Model Number91-0125-01
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 Batchtrue
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
GS110840935107804 [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 Number5
Public Version Date2019-11-08
Device Publish Date2018-01-03

Devices Manufactured by SUNTECH MEDICAL, INC.

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10840935110248 - ProLife2023-06-19
10840935110255 - ProLife2023-06-19
10840935110262 - ProLife2023-06-19
10840935110279 - SunTech APC2023-06-19

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