Duns Number:044611812
Device Description: AllPoints Dressing Change System with Fixed Post Statlock and BioPatch
Catalog Number
APDCSFB1
Brand Name
AllPoints
Version/Model Number
APDCSFB1
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
KMK
Product Code Name
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Public Device Record Key
8bea44b5-e800-4356-8d9e-809af4159ae1
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
June 28, 2017
Package DI Number
10801741137577
Quantity per Package
10
Contains DI Package
00801741137570
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 |