Duns Number:141668116
Device Description: This kit contains: 2 OF9001 Foam Cabinet Filters, 1 BFH65 HEPA Filter 6in Capsule, 1 BF516 This kit contains: 2 OF9001 Foam Cabinet Filters, 1 BFH65 HEPA Filter 6in Capsule, 1 BF516 Final Bacteria Filter.
Catalog Number
OF9001SP
Brand Name
Mobilaire Kit
Version/Model Number
OF9001SP
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JRL
Product Code Name
Unit, Filter, Membrane
Public Device Record Key
8c248b73-27b0-46d5-bac9-14a741f261c1
Public Version Date
August 31, 2018
Public Version Number
1
DI Record Publish Date
July 31, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |