Duns Number:595138793
Device Description: Male / Female Fittings PE line with tubing length 75cm
Catalog Number
682187
Brand Name
CONNECTA™ PE LINE M/F 75CM INT VOL 1.4ML/M
Version/Model Number
682187
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
80f80d8b-093a-415a-a1c3-b61b5080c44e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 2016
Package DI Number
50886333621878
Quantity per Package
250
Contains DI Package
00886333621873
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 |