Duns Number:830864406
Device Description: Pediatric Mouthpiece, each
Catalog Number
-
Brand Name
Spirometrics
Version/Model Number
D1030
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2020
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)
-
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
04f80ad1-492f-413c-8541-53d57c1093cb
Public Version Date
September 24, 2020
Public Version Number
4
DI Record Publish Date
April 03, 2017
Package DI Number
00855784004160
Quantity per Package
3
Contains DI Package
00855784004153
Package Discontinue Date
August 28, 2020
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |