Orbit K

GUDID 10840935100997

SUNTECH MEDICAL, INC.

Automatic-inflation electronic sphygmomanometer, non-portable
Primary Device ID10840935100997
NIH Device Record Key4f0b172b-136f-43b9-bcdd-4fbc03abf2be
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrbit K
Version Model Number98-0062-21
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110840935100997 [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 Date2016-09-12

On-Brand Devices [Orbit K]

1084093510802398-0062-26
1084093510102498-0062-25
1084093510101798-0062-23
1084093510100098-0062-22
1084093510099798-0062-21
1084093510098098-0062-05
1084093510097398-0062-03
1084093510096698-0062-02
1084093510095998-0062-01
1084093510094298-0061-05
1084093510093598-0061-03
1084093510092898-0061-02
1084093510091198-0061-01
1084093510948898-0061-25
1084093510954998-0062-37
1084093510953298-0062-36
1084093510952598-0.062-35
1084093510951898-0062-34
1084093510950198-0061-27
1084093510949598-0061-26
1084093510947198-0061-24

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