Duns Number:058614483
Device Description: Re/X700 Reusable Expiratory Filter for 700 Series Ventilators
Catalog Number
-
Brand Name
Puritan Bennett
Version/Model Number
G-060525-00
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
ccf951e7-4406-4857-8f82-86969a6e19b7
Public Version Date
August 09, 2022
Public Version Number
4
DI Record Publish Date
December 24, 2020
Package DI Number
20884521810133
Quantity per Package
30
Contains DI Package
10884521810136
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 |