Duns Number:206449154
Device Description: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilation at a r The Adult Ventilation Timer is intended to guide the rescuer to provide ventilation at a rate appropriate for adult patients.The LED light on the 01BM1000 is powered by a 3.0V coin battery to provide 10BPM flashing rate (1.5 sec ON, 4.5 sec OFF).
Catalog Number
01BM1000-CS
Brand Name
O-Two
Version/Model Number
01BM1000
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"
-
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
JBS
Product Code Name
Timer, General Laboratory
Public Device Record Key
f4a6180c-9e95-442b-9835-c247a06fdb35
Public Version Date
May 13, 2019
Public Version Number
1
DI Record Publish Date
May 03, 2019
Package DI Number
17540195004501
Quantity per Package
50
Contains DI Package
07540195004504
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |