Duns Number:488293218
Device Description: Suction jar for reusable collection system
Catalog Number
-
Brand Name
Suction jar polysulfone, 0.5l
Version/Model Number
077.0155
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130123,K130123
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
cc104b86-e7c9-4eb3-bab2-e9bc45538755
Public Version Date
January 08, 2021
Public Version Number
5
DI Record Publish Date
October 24, 2016
Package DI Number
07612367031448
Quantity per Package
27
Contains DI Package
07612367002684
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 93 |