DEVICE: CPS™ (05414734504287)

Device Identifier (DI) Information

CPS™
Implant Kit
Not in Commercial Distribution
410190
ST. JUDE MEDICAL, INC.
05414734504287
GS1
December 01, 2016
1
790268031 *Terms of Use
Cardiac Positioning System(CPS™)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vascular guide-catheter, single-use A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DQY CATHETER, PERCUTANEOUS
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Store in a cool, dark, dry place.Do not use if package is damaged.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

7b488f53-01e6-43e1-b63c-2b3e8ca4df46
March 29, 2018
2
April 21, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
CLOSE