DEVICE: CPS DIRECT™ (05414734206822)

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Device Identifier (DI) Information

CPS DIRECT™
PL
410174
ST. JUDE MEDICAL, INC.
05414734206822
GS1
1
No description.
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Device Characteristics

MR Unsafe
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
Cardiovascular device introducer, non-steerable A sterile tubular sheath designed for percutaneous placement in the cardiovascular system and through which other cardiovascular devices (e.g., cardiac/intravascular catheter, pacing lead) are subsequently inserted for positioning in blood vessels and/or chambers of the heart. The non-steerable distal tip is typically curved to accommodate manoeuvring in the cardiac anatomy. It may be fitted with a haemostasis valve (HV) to minimize blood loss during the intervention [e.g., electrophysiology (EP)], have a sideport for aspiration/infusion/blood sampling, have radiopaque graduated markings making it x-ray visible, and may include a dedicated intraluminal dilator. This is a single-use device.
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FDA Product Code

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Special Storage Condition, Specify: Store in a cool, dark, dry place.
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: OC-W
Catheter Gauge: 9 French
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Device Status

In Commercial Distribution
April 01, 2015

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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
No Package DIs found
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Secondary DI

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