Duns Number:603048778
Device Description: Phasitron Kit, IPV HC-1D, Single Patient (New name for A50110-HC-OP A-D, same product.)
Catalog Number
A50110-HC-1D
Brand Name
Percussionaire
Version/Model Number
A50110-HC-1D
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 16, 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K905236
Product Code
NHJ
Product Code Name
Device, Positive Pressure Breathing, Intermittent
Public Device Record Key
8924a3b3-fae9-484d-ae43-8543e2296e93
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
October 22, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |