Duns Number:807537683
Device Description: Portable Liquid Oxygen Respirator Equipment, Top Fill, 15 LPM, 20 PSI
Catalog Number
-
Brand Name
Companion 1000
Version/Model Number
B-775532-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K861503
Product Code
BYJ
Product Code Name
Unit, Liquid-Oxygen, Portable
Public Device Record Key
ac0fa496-10f9-42f1-bd02-90659a9f8eea
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 252 |