Duns Number:050334275
Device Description: e360 Ventilator with Accessories S Model
Catalog Number
E360S-US-NA
Brand Name
Newport
Version/Model Number
E360S-US-NA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101803
Product Code
CBK
Product Code Name
VENTILATOR, CONTINUOUS, FACILITY USE
Public Device Record Key
3843936b-bec3-419a-8d8b-b561bcaa0b5e
Public Version Date
October 22, 2020
Public Version Number
5
DI Record Publish Date
June 07, 2019
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |