Duns Number:357007657
Device Description: Ventilator Non-continuous (Respirator)
Catalog Number
205000
Brand Name
Breas iSleep 20 System
Version/Model Number
US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 15, 2018
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
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
322f2fa6-e130-40a9-b172-7fbff973a59d
Public Version Date
February 11, 2021
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
07321822050169
Quantity per Package
1
Contains DI Package
07321822050008
Package Discontinue Date
January 15, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |