Duns Number:544474402
Device Description: Electric Nasal Aspirator
Catalog Number
-
Brand Name
joyhicare
Version/Model Number
HTD2602US
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
-
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
d95caa4b-dee4-4cab-8f87-3dfa7374ec52
Public Version Date
October 14, 2021
Public Version Number
1
DI Record Publish Date
October 06, 2021
Package DI Number
16970289035370
Quantity per Package
60
Contains DI Package
06970289035373
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 53 |