DEVICE: CPS DIRECT™ (05414734218337)

Device Identifier (DI) Information

CPS DIRECT™
DS2A004
In Commercial Distribution
DS2A004
ST. JUDE MEDICAL, INC.
05414734218337
GS1

1
790268031 *Terms of Use
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, steerable A sterile, steerable, tubular sheath designed for percutaneous placement in/near the cardiovascular system and through which other cardiovascular devices (e.g., cardiac/intravascular catheter, pacing lead) are subsequently inserted for positioning in blood vessels, heart chambers, or on epicardial surfaces. The distal tip is actuated via controls at the proximal end to accommodate manoeuvring in/around the heart. It may be fitted with a haemostasis valve (HV) to minimize blood loss during intervention [e.g., electrophysiology (EP)], a sideport for aspiration/infusion/blood sampling, have radiopaque markings, 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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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
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Special Storage Condition, Specify: Store in a cool, dark, dry place.
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between -5 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

53c481c1-1ee8-47a8-ab75-cd3015c8eefb
March 29, 2018
2
March 19, 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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