Duns Number:053146767
Device Description: BE 1000-2 Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation ba BE 1000-2 Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation bag. This is an accessory to the BE 3000 Series Oxygen Instant Flow Valves. Reusable.
Catalog Number
BE 1000-2
Brand Name
BE 1000-2 O2 Instant Flow Valve Bag Hanger
Version/Model Number
BE 1000-2
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"
Yes
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
K970959
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
022854cf-a6dc-454b-adee-c393d78be8c4
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
May 31, 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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |