Duns Number:659177273
Device Description: The U-DAB Blades are used with the video laryngoscope to assist endotracheal intubations f The U-DAB Blades are used with the video laryngoscope to assist endotracheal intubations for difficult airways.
Catalog Number
700180
Brand Name
APA™ U-DAB (clean, non-sterile)
Version/Model Number
700180
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
d623833a-a579-4d3f-9dd6-b6d503a4492b
Public Version Date
October 23, 2018
Public Version Number
1
DI Record Publish Date
September 22, 2018
Package DI Number
28885009190060
Quantity per Package
20
Contains DI Package
18885009190063
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper 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 |