Duns Number:068156330
Device Description: DISPOSABLE ULTRAFLOW RESPIRATION MONITORS: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 O DISPOSABLE ULTRAFLOW RESPIRATION MONITORS: LARGE, SINGLE CHANNEL (2 PLUGS, 1 CHANNEL), 1 ORAL & 2 NASAL RECORDING POINTS
Catalog Number
-
Brand Name
UltraFlow™
Version/Model Number
603775
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 20, 2019
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
BZQ
Product Code Name
Monitor, Breathing Frequency
Public Device Record Key
d54e97bb-82b9-4b33-93eb-016f2467e452
Public Version Date
May 21, 2019
Public Version Number
3
DI Record Publish Date
September 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 83 |