Duns Number:025460908
Device Description: FILTER, HEAT AND MOISTURE
Catalog Number
DYNJAA157
Brand Name
Medline
Version/Model Number
DYNJAA157
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
K132709,K132709
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
eed18af7-099e-4597-8f7a-bda279a9eed5
Public Version Date
January 31, 2022
Public Version Number
2
DI Record Publish Date
April 05, 2021
Package DI Number
40888277361240
Quantity per Package
25
Contains DI Package
10888277361249
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 |