Duns Number:134139174
Device Description: ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID MANAGEMENT SOFTWARE FEATURE RED CAP FIVE ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID MANAGEMENT SOFTWARE FEATURE RED CAP FIVE PACK
Catalog Number
AIQSAFM8R5
Brand Name
ACUMEN IQ SENSOR FOR AFM
Version/Model Number
AIQSAFM8R5
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,K152980
Product Code
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
d7bfca10-57ab-4d6c-92f9-58385c6e2bb8
Public Version Date
July 17, 2019
Public Version Number
1
DI Record Publish Date
July 09, 2019
Package DI Number
50690103201067
Quantity per Package
5
Contains DI Package
00690103201062
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 |