Duns Number:338493631
Device Description: (8 Gal CHEMO USA YELL Disposable Container w/Port/Duo Lid) Single EA
Catalog Number
-
Brand Name
APmedical
Version/Model Number
FGSC30DYC001 SC30DY
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
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
K071517
Product Code
MMK
Product Code Name
Container, Sharps
Public Device Record Key
50056995-d334-41fa-871c-831c278caefa
Public Version Date
November 06, 2019
Public Version Number
4
DI Record Publish Date
February 10, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 92 |