Duns Number:305682023
Device Description: Ambu aScope BronchoSampler A Single-use, sterile and closed-loop system for bronchoscopic Ambu aScope BronchoSampler A Single-use, sterile and closed-loop system for bronchoscopic specimen sampling. Set included 2 container, 1 interface for sampling and 1 suction adapter. For integration with Ambu aScope 4 Broncho. Container volume 30ml, ETO sterilisation method. Minimum ordering is 5 pcs = 1 box
Catalog Number
480200000
Brand Name
aScope BronchoSampler™Specimen Sampling System - Single Use
Version/Model Number
480200000
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"
Yes
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
-
Product Code
CBC
Product Code Name
BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED)
Public Device Record Key
262182b4-084c-4c80-a204-338999359040
Public Version Date
October 30, 2019
Public Version Number
2
DI Record Publish Date
January 30, 2019
Package DI Number
05707480137114
Quantity per Package
5
Contains DI Package
05707480137107
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |