Duns Number:184817096
Device Description: KoKo Standard Pulmonary Function Filter Kit, White with Cardboard Mouthpiece. 26.3mm ID x KoKo Standard Pulmonary Function Filter Kit, White with Cardboard Mouthpiece. 26.3mm ID x 30mm OD for use with MicroMedical, Vitalograph, Schiller, MultiSpiro/Creative Biomedics, MIR. Box of 100.
Catalog Number
851010
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
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
bd7fc640-b488-4e75-a0f1-2f37f6fc0bbb
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 |