Oscar 2

GUDID 10840935107484

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder
Primary Device ID10840935107484
NIH Device Record Keya853839a-c08f-4cc7-be39-5e5550e9284b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOscar 2
Version Model Number99-0133-10
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110840935107484 [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 Date2017-06-10

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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