SphygmoCor

GUDID 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer

ATCOR MEDICAL PTY LTD

Patient monitoring system module, multifunction
Primary Device ID19351315000017
NIH Device Record Keyd490db9a-5c83-4f48-9527-49012db72b13
Commercial Distribution StatusIn Commercial Distribution
Brand NameSphygmoCor
Version Model NumberCVMS
Company DUNS751626706
Company NameATCOR MEDICAL PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS119351315000017 [Primary]
GS119351315000024 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [SphygmoCor]

19351315000031Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus vari
19351315000017Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus vari

Trademark Results [SphygmoCor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPHYGMOCOR
SPHYGMOCOR
74660227 2193986 Live/Registered
ATCOR MEDICAL PTY LTD
1995-04-07

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