Duns Number:488293218
Device Description: Diposable virus / odour Filter with conical Connections
Catalog Number
-
Brand Name
Diposable virus / odour Filter
Version/Model Number
101035289
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
K130123,K130123,K130123
Product Code
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
4bd1f371-f0b7-4fa6-a6c9-ab980a3cd090
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
Package DI Number
07612367064903
Quantity per Package
20
Contains DI Package
07612367064897
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 |