Duns Number:305682023
Device Description: Ambu aScope BronchSampler container. Single-use and sterile. Volume of container: 30 ml Mi Ambu aScope BronchSampler container. Single-use and sterile. Volume of container: 30 ml Minimum purchase is 10 pcs. = 1 box
Catalog Number
480300000
Brand Name
aScope BronchoSampler™ SC
Version/Model Number
480300000
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
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
a906f939-7019-47bc-8403-686586ac121f
Public Version Date
September 04, 2020
Public Version Number
1
DI Record Publish Date
August 27, 2020
Package DI Number
05707480137084
Quantity per Package
10
Contains DI Package
05707480137077
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 |