Duns Number:006261481
Device Description: CATH PCP050120090 PLUS US 05L120UL0900
Catalog Number
-
Brand Name
Pacific™ Plus
Version/Model Number
PCP050120090
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 21, 2019
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123358
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
ac000295-2ab4-4ffc-a4f3-772ae29e86b0
Public Version Date
March 17, 2022
Public Version Number
5
DI Record Publish Date
June 22, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |