Duns Number:315578914
Catalog Number
-
Brand Name
APack Basic Ped,CS Mask Straw3
Version/Model Number
MP01684
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
b0b3ee15-0201-48a5-8d61-544a569ad1e0
Public Version Date
October 24, 2022
Public Version Number
7
DI Record Publish Date
October 24, 2015
Package DI Number
04048675252436
Quantity per Package
5
Contains DI Package
04048675420965
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 220 |
2 | A medical device with a moderate to high risk that requires special controls. | 160 |