Duns Number:196548481
Device Description: SafeAir ULPA Filter
Catalog Number
0703-040-000
Brand Name
Neptune
Version/Model Number
0703-040-000
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
-
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
4386f17a-0ddd-4f6d-9186-c3808a935f68
Public Version Date
July 01, 2020
Public Version Number
3
DI Record Publish Date
October 17, 2019
Package DI Number
37613327466325
Quantity per Package
24
Contains DI Package
07613327466324
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |