Duns Number:595138793
Device Description: 60 drops, 60" tube length AdSet packs with a Critiflo Dome connected with a 36" pressure 60 drops, 60" tube length AdSet packs with a Critiflo Dome connected with a 36" pressure Tubing & a 3-way White stopcock. It also includes a separately packed 2x male protective caps.
Catalog Number
682119
Brand Name
CRITIFLO(TM) TAK1536T
Version/Model Number
682119
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
3dda0f81-8a66-454f-8931-445eaf1cffe8
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2016
Package DI Number
50886333621199
Quantity per Package
50
Contains DI Package
00886333621194
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 |