Duns Number:603048778
Device Description: IPV Phasitron Breathing Circuit Kit, Single Patient, Hospital Phasitron 5
Catalog Number
P5
Brand Name
Percussionaire
Version/Model Number
P5
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
K905236,K905236
Product Code
NHJ
Product Code Name
Device, Positive Pressure Breathing, Intermittent
Public Device Record Key
6458d808-4d26-4a2e-8d3c-1d7cc81f90f7
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
December 03, 2018
Package DI Number
10849436000508
Quantity per Package
10
Contains DI Package
00849436000501
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |