Duns Number:055363428
Device Description: ASSEMBLY, FINAL, M330 ASPIRATOR
Catalog Number
-
Brand Name
Aspirator
Version/Model Number
798-0330-01
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
BTA
Product Code Name
PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Public Device Record Key
28f804a0-b747-42ae-b14d-36a6c6bff173
Public Version Date
August 23, 2018
Public Version Number
3
DI Record Publish Date
September 06, 2017
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 | 10 |
2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
3 | A medical device with high risk that requires premarket approval | 1032 |