Duns Number:830201237
Catalog Number
-
Brand Name
first essentials Nasal Aspirator
Version/Model Number
76087
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
e6456a8c-5c13-4210-a73d-4995fdb54982
Public Version Date
May 17, 2019
Public Version Number
1
DI Record Publish Date
May 09, 2019
Package DI Number
10885131760873
Quantity per Package
4
Contains DI Package
80885131760872
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugate Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |