Duns Number:184817096
Device Description: KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece 30mm ID x 34mm OD for KoKo Standard White Filter Kit with Nose Clip and Rubber Mouthpiece 30mm ID x 34mm OD for use with most SensorMedics models. Box of 50.
Catalog Number
831580
Brand Name
nSpire Health
Version/Model Number
KoKo Filter Kit
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
Yes
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
BXJ
Product Code Name
Clip, Nose
Public Device Record Key
320ed79b-1856-4448-b3fc-9092ba4c54b7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |