Duns Number:220018415
Device Description: Threshold PEP (735), 10 pack.
Catalog Number
HS735-010
Brand Name
THRESHOLD
Version/Model Number
00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K961077
Product Code
BWF
Product Code Name
SPIROMETER, THERAPEUTIC (INCENTIVE)
Public Device Record Key
b40477e4-93f1-4e0c-8c96-a5026197bf17
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
August 24, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |
2 | A medical device with a moderate to high risk that requires special controls. | 399 |