Duns Number:044611812
Device Description: Port Access Kit
Catalog Number
CPA00010
Brand Name
SafeStep
Version/Model Number
CPA00010
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
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
17ac40ee-a0f5-4a91-998c-e616c1daee0f
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
June 18, 2016
Package DI Number
10801741107341
Quantity per Package
5
Contains DI Package
00801741107344
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 |