Duns Number:058614483
Device Description: Electrostatic Spirometry Filter Adapter
Catalog Number
-
Brand Name
DAR
Version/Model Number
R021
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 23, 2021
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
-
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
77e3f92b-f5d0-442e-ba8d-9e00ec50d12a
Public Version Date
March 08, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
10884522032216
Quantity per Package
10
Contains DI Package
20884522032213
Package Discontinue Date
February 23, 2021
Package Status
Not 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 |