Duns Number:184817096
Device Description: KoKo Elliptical Pulmonary Function Filter, White for KoKo Sx, KoKo Legend, KoKo DigiDoser, KoKo Elliptical Pulmonary Function Filter, White for KoKo Sx, KoKo Legend, KoKo DigiDoser, and KoKo Trek Spirometers. Box of 100.
Catalog Number
916000
Brand Name
nSpire Health
Version/Model Number
KoKo Filter
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
K934475,K934475
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
df238aec-73db-458c-8d09-dc98f95dd906
Public Version Date
July 06, 2018
Public Version Number
3
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 |