Duns Number:097736867
Device Description: ASEPT 600mL Drainage Bottle with Y-Site Drain
Catalog Number
M7052
Brand Name
ASEPT
Version/Model Number
M7052
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)
Yes
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
2ebffa86-6cc1-49f3-a956-4efcc1f5bf2a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 05, 2016
Package DI Number
10813623015743
Quantity per Package
10
Contains DI Package
00813623015746
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 109 |