Duns Number:020275145
Device Description: Adapter, Tube, Plexiglas, 1 1/2 TO 1 3/8
Catalog Number
114000
Brand Name
Adapter, Tube, Plexiglas, 1 1/2 TO 1 3/8
Version/Model Number
Adapter, Plexiglas, 1 1/2 TO 1 3/8 - 114000
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
-
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
9a38642b-fe38-4547-91e3-eee1ba512ced
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
December 10, 2019
Package DI Number
00817081022933
Quantity per Package
1
Contains DI Package
00817081022926
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 | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |