Duns Number:002348191
Device Description: PEDIATRIC VOLDYNE VOLUMETRIC EXERCISER
Catalog Number
8884719017
Brand Name
HUDSON RCI
Version/Model Number
IPN049317
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K801199,K801199,K801199
Product Code
BWF
Product Code Name
SPIROMETER, THERAPEUTIC (INCENTIVE)
Public Device Record Key
0dd71503-0a23-4da5-bca6-9f05a25da9aa
Public Version Date
August 19, 2020
Public Version Number
2
DI Record Publish Date
August 10, 2018
Package DI Number
34026704630180
Quantity per Package
12
Contains DI Package
14026704630186
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |