Duns Number:002348191
Device Description: Arterial Catheterization Set
Catalog Number
SAC-00520
Brand Name
ARROW
Version/Model Number
IPN030309
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
K093050,K093050
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
4c1ae096-eeb6-49a1-99ea-6685d15a1121
Public Version Date
June 21, 2022
Public Version Number
10
DI Record Publish Date
September 16, 2016
Package DI Number
30801902102745
Quantity per Package
10
Contains DI Package
00801902102744
Package Discontinue Date
June 14, 2022
Package Status
Not 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 |