Duns Number:393789540
Device Description: Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function te Body plethysmograph with DLCO He Dilution. Inspiratory bag. XL Size. Pulmonary function testing, measuring lung volumes and airway resistance by spirometry and body plethysmography.
Catalog Number
BB-00-02
Brand Name
BodyBox
Version/Model Number
DLCO He IB Si XL
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
K022636
Product Code
JEH
Product Code Name
Plethysmograph, Volume
Public Device Record Key
959d9525-3379-4c60-a06e-5751e1c7d838
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |