Duns Number:006261481
Device Description: ADAPTER AC4002M TRI W/METAL GDWR 5PK
Catalog Number
-
Brand Name
PITON™ TRI-ADAPTOR
Version/Model Number
AC4002M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2019
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
K940063,K940063
Product Code
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
4f3dbf8e-de79-4fca-9d62-23066b1ba354
Public Version Date
September 22, 2022
Public Version Number
5
DI Record Publish Date
July 02, 2016
Package DI Number
00681490225748
Quantity per Package
5
Contains DI Package
70681490225747
Package Discontinue Date
October 21, 2019
Package Status
Not in Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |