Duns Number:203298203
Device Description: EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN
Catalog Number
-
Brand Name
EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN
Version/Model Number
105030
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080926,K080926,K080926
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
0336770b-6b8f-4608-9988-bb573ce8948b
Public Version Date
February 27, 2020
Public Version Number
1
DI Record Publish Date
February 19, 2020
Package DI Number
10762860050300
Quantity per Package
10
Contains DI Package
00762860050303
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |