Oscar 2

GUDID 10840935105343

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder
Primary Device ID10840935105343
NIH Device Record Keyf9c8bc28-e173-4656-b09f-2ddb2271192d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOscar 2
Version Model Number99-0012-09
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 Numbertrue
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

Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com
Phone+1-919-654-2300
EmailUDI_MAIL@suntechmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110840935105343 [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 Date2016-09-12

On-Brand Devices [Oscar 2]

1084093510285498-0239-04
1084093510284798-0239-03
1084093510283098-0239-02
1084093510282398-0239-01
1084093510881899-0133-07
1084093510880199-0133-06
1084093510879599-0133-05
1084093510878899-0133-04
1084093510751499-0133-13
1084093510750799-0133-12
1084093510749199-0133-11
1084093510748499-0133-10
1084093510679199-0133-03
1084093510678499-0133-01
1084093510598599-0133-02
1084093510597899-0133-00
1084093510537499-0012-41
1084093510536799-0012-29
1084093510534399-0012-09
1084093510533699-0012-00
1084093510965599-0133-50
1084093510995299-0133-17
1084093510994599-0133-16
1084093510993899-0133-15
1084093510992199-0133-14

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