Duns Number:044611812
Device Description: AllPoints Dressing Change System for Dialysis with BioPatch
Catalog Number
APDCSDB1
Brand Name
AllPoints
Version/Model Number
APDCSDB1
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OXQ
Product Code Name
Dressing change tray
Public Device Record Key
44f8becb-ca80-4298-8dd8-630fceeca8cf
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
June 28, 2017
Package DI Number
10801741137614
Quantity per Package
10
Contains DI Package
00801741137617
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |