Duns Number:141668116
Device Description: Combo pack of Covidien Nellcor Puritan Bennett GoodKnight 420/425 Style, 1 Foam and 2 Ultr Combo pack of Covidien Nellcor Puritan Bennett GoodKnight 420/425 Style, 1 Foam and 2 Ultrafine Filters.
Catalog Number
CF6003Combo
Brand Name
Combo Pack
Version/Model Number
CF6003Combo
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"
Yes
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
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
8a819e89-30c8-464e-8183-f24af58c3fd2
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
June 01, 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 |