Duns Number:595138793
Device Description: A standalone 60 drops, 60" tube 1-way Adset packs with a Critiflo assembled with Velcro st A standalone 60 drops, 60" tube 1-way Adset packs with a Critiflo assembled with Velcro strap & Adhesive pad. It is connected to a 3-way OFF white stopcock and a 12' Female/ Male Pressure tubing. It also includes a separately packed 2x male protective caps.
Catalog Number
682130
Brand Name
CRITIFLO(TM) TAK1712SM
Version/Model Number
682130
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
f9ab0990-9d52-4751-9483-d1414e6312b7
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50886333621304
Quantity per Package
50
Contains DI Package
00886333621309
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 |