Duns Number:044611812
Device Description: AllPoints Dressing Change System for Dialysis
Catalog Number
APDCSDG1
Brand Name
AllPoints
Version/Model Number
APDCSDG1
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
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
dcef4f3d-ea07-469e-b09e-4a600347ed94
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
June 28, 2017
Package DI Number
10801741137607
Quantity per Package
10
Contains DI Package
00801741137600
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 |