Duns Number:058614483
Device Description: Neonatal Flow and CO2 Sensor Disposable;For 980 Series Ventilator
Catalog Number
-
Brand Name
Puritan Bennett
Version/Model Number
10005002
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"
Yes
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
-
Product Code
BXP
Product Code Name
TRANSDUCER, GAS FLOW
Public Device Record Key
d5cd508f-c97d-40bb-9ae7-5ab97f6bbbb1
Public Version Date
December 02, 2021
Public Version Number
2
DI Record Publish Date
April 15, 2021
Package DI Number
10884521139855
Quantity per Package
10
Contains DI Package
20884521139852
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 |