Duns Number:134139174
Device Description: HEART REFERENCE SENSOR BODY PADS
Catalog Number
EVHRSBP
Brand Name
EV1000
Version/Model Number
EVHRSBP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
Yes
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
K160552,K140312,K140312,K160552,K160552,K140312
Product Code
DSB
Product Code Name
PLETHYSMOGRAPH, IMPEDANCE
Public Device Record Key
81fe895f-4a9c-4edd-8ef2-3383930b4536
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2016
Package DI Number
50690103193492
Quantity per Package
4
Contains DI Package
00690103193497
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |