Duns Number:595138793
Device Description: 60 drops, 60" tube length AdSet packs together with a Critiflo Dome connected with a Dampl 60 drops, 60" tube length AdSet packs together with a Critiflo Dome connected with a Dampling device and a 48" & 12" pressure Tubing and 2x 3-Way White Stopcocks. It includes a separately packed 2x Male protective caps.
Catalog Number
682176
Brand Name
SAK1560T
Version/Model Number
682176
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
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
aaca8ae7-c3fc-4688-8bd4-9d4621cf942b
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
50886333621762
Quantity per Package
25
Contains DI Package
00886333621767
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |