Duns Number:025460908
Device Description: HME, TRACH
Catalog Number
DYNJAAHME30
Brand Name
Medline
Version/Model Number
DYNJAAHME30
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
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
BYD
Product Code Name
CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Public Device Record Key
90b51a19-c685-4641-92f6-1dda9a2a1761
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 11, 2022
Package DI Number
40888277333421
Quantity per Package
50
Contains DI Package
10888277333420
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |