Duns Number:097736867
Device Description: ASEPT Drainage Bag with Procedure Pack
Catalog Number
M7060
Brand Name
ASEPT Peritoneal Drainage System
Version/Model Number
M7060
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
K093796,K093796
Product Code
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
96293d00-2b52-4e1d-bb80-b3b284e4374c
Public Version Date
September 05, 2019
Public Version Number
4
DI Record Publish Date
October 15, 2015
Package DI Number
10813623014227
Quantity per Package
10
Contains DI Package
00813623014220
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 |