Duns Number:044611812
Device Description: AllPoints Port Access System SafeStep 20G x 1 inch + GuardIVa
Catalog Number
AN162010G
Brand Name
Port Access
Version/Model Number
AN162010G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
b4275675-d1a7-4754-a244-1dea4ab49e1f
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
April 07, 2016
Package DI Number
10801741119443
Quantity per Package
10
Contains DI Package
00801741119446
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 |