Duns Number:058614483
Device Description: Adult-Pediatric Electrostatic Filter HME,Small, Tethered Cap
Catalog Number
-
Brand Name
DAR
Version/Model Number
352/5877TC
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
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
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
62e61994-3023-4760-984b-e0d392f2c7c0
Public Version Date
January 11, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
30884522012274
Quantity per Package
25
Contains DI Package
40884522012271
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |