Duns Number:131904450
Device Description: Sprout Ware® Nasal Aspirator made from Plants and Silicone-Tube-Green-Adult Use Only
Catalog Number
-
Brand Name
Green Sprouts
Version/Model Number
309305-500-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 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
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
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
027eceee-4c3f-4fc4-8f3d-2a86a923d7ea
Public Version Date
April 22, 2021
Public Version Number
1
DI Record Publish Date
April 14, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 53 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |