Duns Number:305682023
Device Description: aScope BronchoSampler 60 SC / US
Catalog Number
480500000US
Brand Name
aScope BronchoSampler™ 60 SC
Version/Model Number
480500000US
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
-
Product Code
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
c84d4289-6fac-4226-bc8f-29a209da2ed6
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 2022
Package DI Number
05707480156580
Quantity per Package
10
Contains DI Package
05707480156573
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 |