Duns Number:006261481
Device Description: EXT CARDIAC AVIVO11 1WK KIT US PHAR TUV
Catalog Number
-
Brand Name
AVIVO™
Version/Model Number
AVIVO11
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2018
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
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
K153160
Product Code
DSB
Product Code Name
PLETHYSMOGRAPH, IMPEDANCE
Public Device Record Key
fda61895-c937-4330-94ec-b31bcd9ea244
Public Version Date
November 10, 2021
Public Version Number
7
DI Record Publish Date
January 14, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |