Duns Number:488293218
Device Description: Disposable Overflow Protection / Virus Odour Filter with conical Connections
Catalog Number
-
Brand Name
Disposable Overflow Protection / Virus Odour Filter
Version/Model Number
101035287
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
-
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
1520055a-411f-4492-97ca-692be4506383
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
Package DI Number
07612367064781
Quantity per Package
20
Contains DI Package
07612367064774
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 |