AccessGUDID - DEVICE: CPS™ (05414734504287)

GUDID

Device Identifier (DI) Information

Brand Name: CPS™
Version or Model: Implant Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 410190
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734504287
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Cardiac Positioning System(CPS™)

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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 [?]
K053277	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b488f53-01e6-43e1-b63c-2b3e8ca4df46
Public Version Date: October 28, 2024
Public Version Number: 7
DI Record Publish Date: April 21, 2016