Duns Number:023869365
Device Description: LifePulse High Frequency Ventilator - Patient Circuit with LifePort Adapters (2.5, 3.0, 3. LifePulse High Frequency Ventilator - Patient Circuit with LifePort Adapters (2.5, 3.0, 3.5) Kit
Catalog Number
-
Brand Name
Bunnell
Version/Model Number
903
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
P850064,P850064,P850064,P850064
Product Code
LSZ
Product Code Name
Ventilator, High Frequency
Public Device Record Key
10044311-7573-439e-af3c-a97e46597aaf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 30, 2017
Package DI Number
10616120000089
Quantity per Package
2
Contains DI Package
00616120000082
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 5 |