Duns Number:020275145
Device Description: Disposable Pulmonary Function Testing Nose Clip with Foam Pads
Catalog Number
166500
Brand Name
Disposable PFT Nose Clip with Foam Pads
Version/Model Number
Disposable PFT Nose Clip with Foam Pads - 166500
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
BXJ
Product Code Name
Clip, Nose
Public Device Record Key
22492db2-a0da-4434-bf2c-fb7430945ec3
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 25, 2019
Package DI Number
00817081022650
Quantity per Package
100
Contains DI Package
00817081021691
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 |