Duns Number:595138793
Device Description: Male / Female Fittings PE line with tubing length 50cm
Catalog Number
682185
Brand Name
CONNECTA™ PE LINE M/F 50CM INT VOL 1.4ML/M
Version/Model Number
682185
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
FMG
Product Code Name
Stopcock, I.V. Set
Public Device Record Key
c44fc478-3c81-4ad7-9ec6-c55d9d3eb60d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2016
Package DI Number
50886333621854
Quantity per Package
250
Contains DI Package
00886333621859
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 |