Duns Number:071595540
Device Description: ULPA/CHARCOAL FILTER CATRIDGES
Catalog Number
60-5902-001
Brand Name
NA
Version/Model Number
60-5902-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 31, 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
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
2d3046d8-088c-41c3-9390-3c352a893ec2
Public Version Date
September 01, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20848584045456
Quantity per Package
2
Contains DI Package
10848584045459
Package Discontinue Date
August 31, 2021
Package Status
Not in Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |