Duns Number:020275145
Device Description: Scout Tube Disposable Breathing Tube For Spiroscout Spirometer
Catalog Number
165780
Brand Name
Scout Tube Disposable Breathing Tube
Version/Model Number
Scout Tube Disposable Breathing Tube
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
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
-
Product Code
BYP
Product Code Name
Mouthpiece, Breathing
Public Device Record Key
5f29c2e5-0686-4981-b24c-3262d63a2aa3
Public Version Date
March 23, 2020
Public Version Number
2
DI Record Publish Date
January 07, 2020
Package DI Number
00817081024005
Quantity per Package
50
Contains DI Package
00817081023992
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |