DEVICE: CPS™ (05414734508889)

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Device Identifier (DI) Information

CPS™
4F SLITTER
DS2A000
ST. JUDE MEDICAL, INC.
05414734508889
GS1
1
No description.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Catheter slitter A hand-held, surgical instrument used to facilitate the removal of an intravascularly placed catheter, typically a guide catheter used to introduce a variety of transvenous devices [e.g., a balloon catheter, oxygen (O2) and/or other sensors, pacing electrode/leads]. It has a specially shielded steel blade that is integrated into the handle. The exposed end of the transvenous device is typically placed and held in a protective channel of this device (the slitter) and the physician pulls the proximal end of the catheter against the blade in a smooth, firm, motion; this splits open the catheter hub and the tubing wall, leaving the transvenous device intact, in situ. This is a single-use device.
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FDA Product Code

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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

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

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Size Type Text
Catheter Gauge: 4 French
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Device Status

In Commercial Distribution
March 30, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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