Duns Number:544474402
Device Description: Electric Nasal Aspirator
Catalog Number
-
Brand Name
Hetaida
Version/Model Number
HTD2601US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 14, 2021
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
40b82978-d3b9-4deb-94e6-d7f3da27d586
Public Version Date
May 14, 2021
Public Version Number
3
DI Record Publish Date
March 10, 2021
Package DI Number
16970289035257
Quantity per Package
28
Contains DI Package
06970289035250
Package Discontinue Date
March 11, 2021
Package Status
Not 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 |