Duns Number:219683489
Device Description: 4300 PEAK FLOW METER myPEF UNIVERSAL DE (NON WEB)
Catalog Number
-
Brand Name
PFM
Version/Model Number
4300
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K781922,K781922,K781922
Product Code
BXW
Product Code Name
CALIBRATOR, VOLUME, GAS
Public Device Record Key
1093d779-bfe5-4401-a82f-833bd108da40
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 08, 2016
Package DI Number
55099169439035
Quantity per Package
40
Contains DI Package
35099169439031
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 189 |