Duns Number:080384219
Device Description: 22mm O.D. x 28mm I.D. x 22mm I.D. x 4.5mmO.D. MOUTHPIECE ADAPTER
Catalog Number
-
Brand Name
T-PIECE ADAPTER
Version/Model Number
1
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
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
e1b5f1bb-92b4-44f1-8a7a-97dd07279edb
Public Version Date
March 23, 2020
Public Version Number
2
DI Record Publish Date
August 23, 2019
Package DI Number
30851232007678
Quantity per Package
10
Contains DI Package
10851232007674
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |