Duns Number:595138793
Device Description: Catheter with 7FR, 4 Lumen, length 110 cm
Catalog Number
680352
Brand Name
CRITICATH SP5107S TD CATHETER
Version/Model Number
680352
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)
Yes
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
KRB
Product Code Name
Probe, Thermodilution
Public Device Record Key
7f641a12-5b17-493a-8843-510cf3fee6ac
Public Version Date
March 10, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
50886333603522
Quantity per Package
20
Contains DI Package
00886333603527
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Tray
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |