Duns Number:285985615
Device Description: Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of t Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable monitor (Screeni). Min. purchase is 5 pcs. = 1 box
Catalog Number
20030001
Brand Name
Broncoflex Agile
Version/Model Number
20030001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202180,K202180
Product Code
EOQ
Product Code Name
Bronchoscope (Flexible Or Rigid)
Public Device Record Key
e1830c42-c8c0-4564-ac68-b533567ebbbf
Public Version Date
December 18, 2020
Public Version Number
1
DI Record Publish Date
December 10, 2020
Package DI Number
03664977120030
Quantity per Package
5
Contains DI Package
03664977020033
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |