Duns Number:751626706
Device Description: Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plu Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others].CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL:• CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].• CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)]• CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
Catalog Number
-
Brand Name
SphygmoCor
Version/Model Number
CVMS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070795,K080670,K070795,K080670
Product Code
DRT
Product Code Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Public Device Record Key
d490db9a-5c83-4f48-9527-49012db72b13
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-