Duns Number:002348191
Device Description: Voldyne 4000 Volumetric Exerciser, CE
Catalog Number
8884719016
Brand Name
HUDSON RCI
Version/Model Number
IPN049104
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"
Yes
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
K182847,K182847
Product Code
BWF
Product Code Name
SPIROMETER, THERAPEUTIC (INCENTIVE)
Public Device Record Key
86816e13-d580-47f4-8275-8ee5e81178d9
Public Version Date
September 30, 2021
Public Version Number
1
DI Record Publish Date
September 22, 2021
Package DI Number
24026704615258
Quantity per Package
12
Contains DI Package
14026704615251
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |