Duns Number:002348191
Device Description: INCENTIVE SPIROMETER,INTL
Catalog Number
41750
Brand Name
HUDSON RCI
Version/Model Number
IPN044469
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K781831,K781831
Product Code
BWF
Product Code Name
SPIROMETER, THERAPEUTIC (INCENTIVE)
Public Device Record Key
c7647db8-c70e-4ee6-bdbc-c58ade1846df
Public Version Date
November 04, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
24026704390513
Quantity per Package
10
Contains DI Package
04026704390519
Package Discontinue Date
September 30, 2019
Package Status
Not 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 |