Duns Number:058614483
Device Description: Re/X800 Reusable Expiratory Bacterial Filter Drain System 800 Series Ventilators
Catalog Number
-
Brand Name
Puritan Bennett
Version/Model Number
4-070305-00
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBK
Product Code Name
VENTILATOR, CONTINUOUS, FACILITY USE
Public Device Record Key
9c4191b1-4977-4bb5-8110-492bab4233d2
Public Version Date
September 21, 2022
Public Version Number
10
DI Record Publish Date
June 07, 2016
Package DI Number
10884521101548
Quantity per Package
20
Contains DI Package
30884521101542
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |