NBP-ONE NJ127

GUDID 10840935109204

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder Blood pressure ambulatory recorder Blood pressure ambulatory recorder
Primary Device ID10840935109204
NIH Device Record Key2520b83c-fa5d-499e-98ec-23aaf3b8c2a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNBP-ONE
Version Model Number91-0032-81
Catalog NumberNJ127
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

Phone919-654-2300
EmailUDI_Mail@suntechmed.com
Phone919-654-2300
EmailUDI_Mail@suntechmed.com
Phone919-654-2300
EmailUDI_Mail@suntechmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110840935109204 [Primary]
GS110840935109204 [Primary]
GS110840935109204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
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 Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [NBP-ONE]

1084093510921198-1020-03
1084093510920491-0032-81
1084093510919891-0143-03

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.