Duns Number:025460908
Device Description: EXCHANGER,HEAT/MOIST,SM,SAMPLE PORT
Catalog Number
DYNJAAHME14
Brand Name
Medline
Version/Model Number
DYNJAAHME14
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
K033008,K033008
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
9992cab2-3299-45ba-bf42-1408f18f436d
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
March 31, 2021
Package DI Number
40884389120379
Quantity per Package
50
Contains DI Package
10884389120378
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 | 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 |