Duns Number:058614483
Device Description: Nasopharyngeal Airway
Catalog Number
-
Brand Name
Shiley
Version/Model Number
8888247031
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"
-
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
K760125,K760125,K760125
Product Code
BTQ
Product Code Name
AIRWAY, NASOPHARYNGEAL
Public Device Record Key
5a98458e-80e6-4b07-9e2f-dba940632407
Public Version Date
February 18, 2022
Public Version Number
2
DI Record Publish Date
August 19, 2018
Package DI Number
50884521133103
Quantity per Package
10
Contains DI Package
40884521133106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |