Duns Number:072656713
Device Description: 30fr Nasopharyngeal Airway, Non-Sterile, Each
Catalog Number
HHNPA-EA
Brand Name
H&H 30fr Nasopharyngeal Airway, Each
Version/Model Number
1.0
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
BTQ
Product Code Name
Airway, Nasopharyngeal
Public Device Record Key
5a86b295-7029-4e34-84e4-550728151003
Public Version Date
January 08, 2021
Public Version Number
1
DI Record Publish Date
December 31, 2020
Package DI Number
10857048006559
Quantity per Package
50
Contains DI Package
00857048006552
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 | 28 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |