Duns Number:659177273
Device Description: The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxyge The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope.
Catalog Number
700330
Brand Name
APA™ O2 MAC 3 Blade
Version/Model Number
700330
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"
Yes
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
K191602,K191602
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
f94f9664-a00f-4824-90c7-c5c968324fc3
Public Version Date
August 30, 2019
Public Version Number
1
DI Record Publish Date
August 22, 2019
Package DI Number
18885009190322
Quantity per Package
10
Contains DI Package
08885009190325
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |