Duns Number:461437429
Device Description: Volumetric Exerciser 4000mL
Catalog Number
-
Brand Name
SPIRO-BALL
Version/Model Number
L25913000
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
K053149,K053149
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
9176dfec-b966-41b2-a012-02d3d0447879
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 12, 2017
Package DI Number
18436020761840
Quantity per Package
12
Contains DI Package
08436020761843
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 77 |