Duns Number:688817949
Device Description: Device 1ea, AC SINGLE CUFF(DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA1 Device 1ea, AC SINGLE CUFF(DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA15 1ea), Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor
Catalog Number
-
Brand Name
DTS-3000
Version/Model Number
DTSW410-SS
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
-
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
-
Product Code
KCY
Product Code Name
Tourniquet, Pneumatic
Public Device Record Key
d2e07b87-a0d6-4217-9bb7-4d0eb1b6e7ce
Public Version Date
June 24, 2021
Public Version Number
1
DI Record Publish Date
June 16, 2021
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |