Duns Number:134139174
Device Description: ACUMEN IQ SENSOR 84" / 213CM Double Line Kit -- With VAMP
Catalog Number
AIQS8S102
Brand Name
ACUMEN IQ SENSOR
Version/Model Number
AIQS8S102
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K152980
Product Code
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
6e4ae7c5-9dd4-4e03-8f78-f08516b2f4c9
Public Version Date
July 17, 2019
Public Version Number
1
DI Record Publish Date
July 09, 2019
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 | 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 |