Duns Number:017535668
Device Description: ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a syringe is ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a syringe is used.
Catalog Number
30-ASP
Brand Name
Aspire Aspirator 30ml
Version/Model Number
30-ASP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
cc275aa8-95b8-4e48-ac72-6f779a1d120e
Public Version Date
January 04, 2021
Public Version Number
5
DI Record Publish Date
August 17, 2017
Package DI Number
B09030ASP1
Quantity per Package
1
Contains DI Package
B09030ASP0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |