Duns Number:141668116
Device Description: This kit contains: 1 OF1001 Foam Cabinet Filter, 1 BF2222 Intake Bacteria Filter, 1 - OF30 This kit contains: 1 OF1001 Foam Cabinet Filter, 1 BF2222 Intake Bacteria Filter, 1 - OF3003 Foam Intake Filter
Catalog Number
OF1001SP-01A
Brand Name
Millennium Kit
Version/Model Number
OF1001SP-01A
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
-
Product Code Name
-
Public Device Record Key
832d793a-7481-4215-8b07-3cd973f40087
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 |