Duns Number:392994778
Device Description: Syringe adaptator - Raccord-réducteur seringue/sonde de petit diamètre - Luer-lock
Catalog Number
00080001
Brand Name
VYGON
Version/Model Number
800.01
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
KYX
Product Code Name
DISPENSER, LIQUID MEDICATION
Public Device Record Key
d7bb1bce-8360-4156-bd9b-d9411525bd7f
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 2021
Package DI Number
53660812114580
Quantity per Package
48
Contains DI Package
33660812114586
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |