Duns Number:656073408
Device Description: ZOOM POD Aspiration Tubing, AFT117B
Catalog Number
-
Brand Name
ZOOM Aspiration Pump
Version/Model Number
AFT117B
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"
Yes
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
JCX
Product Code Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Public Device Record Key
cc13e0fa-8da6-4da4-8271-9a922e7191dc
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 17, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |