Duns Number:002348191
Device Description: Cath-Gard(R) Catheter Contamination Shield for use with Interventional Products - Percutan Cath-Gard(R) Catheter Contamination Shield for use with Interventional Products - Percutaneous Sheath Introducers
Catalog Number
AI-08803
Brand Name
ARROW
Version/Model Number
IPN033834
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K895268,K895268
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
bfda8c6a-aa04-428d-86d9-990d05bb717d
Public Version Date
January 07, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902003158
Quantity per Package
25
Contains DI Package
00801902003157
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |