DEVICE: CPS Courier™ (05414734505178)

Device Identifier (DI) Information

CPS Courier™
Guidewire
In Commercial Distribution
DS2G003
ST. JUDE MEDICAL, INC.
05414734505178
GS1

1
790268031 *Terms of Use
Guidewire, firm
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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
Cardiac/peripheral vascular guidewire, single-use A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DQX WIRE, GUIDE, CATHETER
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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
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Special Storage Condition, Specify: Store in a cool, dark, dry place. Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Length: 195 Centimeter
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Device Record Status

0b2da166-a80e-44d2-9ac6-9815471791bf
March 29, 2018
2
January 24, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15414734505175 5 05414734505178 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC H758DS2G0030
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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