Duns Number:785952607
Device Description: PULMO-PROTECT, PULMONARY FUNCTION FILTER, MOUTHPIECE, NOSE CLIP
Catalog Number
-
Brand Name
PULMO-PROTECT, PULMONARY FUNCTION FILTER, MOUTHPIECE, NOSE CLIP
Version/Model Number
1691016
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K013123,K013123
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
d2f57326-5817-4624-8868-a909796248f9
Public Version Date
July 25, 2022
Public Version Number
1
DI Record Publish Date
July 15, 2022
Package DI Number
05030267160457
Quantity per Package
30
Contains DI Package
05030267160440
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. | 101 |