Duns Number:659177273
Device Description: The laryngoscope with a MIL Blade size 1 attached is used to assist routine endotracheal i The laryngoscope with a MIL Blade size 1 attached is used to assist routine endotracheal intubation in a similar manner to a standard Miller laryngoscope.
Catalog Number
702110
Brand Name
APA™ MIL 1 Blade (clean, non-sterile)
Version/Model Number
702110
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
-
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
607580a1-dd56-495f-b9f4-de6bc4a54d39
Public Version Date
October 23, 2018
Public Version Number
1
DI Record Publish Date
September 22, 2018
Package DI Number
28885009190244
Quantity per Package
20
Contains DI Package
18885009190247
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 |