DEVICE: CPS DIRECT™ (05415067003775)
Device Identifier (DI) Information
CPS DIRECT™
DS2M022
In Commercial Distribution
DS2M022
ST. JUDE MEDICAL, INC.
DS2M022
In Commercial Distribution
DS2M022
ST. JUDE MEDICAL, INC.
MediGuide Enabled Slittable Outer Guide Catheter
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17846 | Vascular guide-catheter, single-use |
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQY | CATHETER, PERCUTANEOUS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dark, dry place. Do not crush. |
Storage Environment Temperature: between -5 and 50 Degrees Celsius |
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit |
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit |
Handling Environment Temperature: between -5 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 47 Centimeter |
Length: 18.5 Inch |
Device Record Status
f3477901-d876-4998-941a-74aedc3ba45b
July 26, 2023
5
April 21, 2016
July 26, 2023
5
April 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com