Duns Number:659177273
Device Description: A non-sterile device typically designed as a moulded plastic sleeve intended to be placed A non-sterile device typically designed as a moulded plastic sleeve intended to be placed over the reusable laryngoscope device during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse
Catalog Number
701011
Brand Name
APA IP Shield™ VL
Version/Model Number
701011
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BRY
Product Code Name
Cabinet, Table And Tray, Anesthesia
Public Device Record Key
26e8667d-d4b9-40a7-97f8-c49486d18f13
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 25, 2019
Package DI Number
28885009190213
Quantity per Package
200
Contains DI Package
18885009190216
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 |