Duns Number:595138793
Device Description: A separate 60 drops, 60" tube Adset packs with a Critiflo dome set connected to pressure t A separate 60 drops, 60" tube Adset packs with a Critiflo dome set connected to pressure tubing and 2x 3-Way White Off stopcocks. It also includes a separately packed 2x male protective caps.
Catalog Number
682120
Brand Name
CRITIFLO(TM) TAK1560T
Version/Model Number
682120
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
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
-
Product Code
DXO
Product Code Name
Transducer, Pressure, Catheter Tip
Public Device Record Key
b61168b3-e62e-4d3d-a7fe-47bec470df83
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
50886333621205
Quantity per Package
50
Contains DI Package
00886333621200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |