Duns Number:058614483
Device Description: 800 Series Options Kit, JAPANESE, Leak Compensation
Catalog Number
-
Brand Name
Puritan Bennett
Version/Model Number
10035878
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 02, 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
-
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
3937b4af-d40a-4c29-bb28-c8290f4f049f
Public Version Date
August 23, 2022
Public Version Number
8
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 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 |