Duns Number:134139174
Device Description: Acumen IQ Cuff Small
Catalog Number
AIQCS
Brand Name
Acumen IQ Cuff
Version/Model Number
AIQCS
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
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
K190130,K190130
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
9f7113bf-2be8-40b5-83e5-8ae35cf3ec1c
Public Version Date
July 21, 2021
Public Version Number
1
DI Record Publish Date
July 13, 2021
Package DI Number
50690103203320
Quantity per Package
5
Contains DI Package
00690103203325
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 |