Duns Number:090508636
Device Description: The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct patient c The VAR-Monitor is mounted onto the exhalation side of the VAR and has no direct patient contact during its operation. If the VAR stops cycling, the VAR-Monitor™ detects the non-cycling condition and generates both an audible sound and a visible blinking (red color LED) light alerting the clinician who is attending the patient.
Catalog Number
VM-3500
Brand Name
VAR-Monitor
Version/Model Number
VM-3500
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
-
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
K073261
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
c3210684-b3a7-4850-9814-090cce7d6a46
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 14, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |