DEVICE: CORD STICK (00861916000306)

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Device Identifier (DI) Information

CORD STICK
MULTIPLE DRAW SYSTEM
2003-001
CORD STICK CORPORATION
00861916000306
GS1
1
The Cord Stick Multiple Draw System is indicated for collection of blood from the umbilical cord after delivery of a new born infant. The blood is for routine laboratory evaluation, only, not for blood banking. The device has engineered sharps protection features intended to protect medical service providers and hospital staff and reduce the chance of needle stick injury.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
Yes
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
Blood collection set, invasive A collection of sterile devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KNA Instrument, Manual, Specialized Obstetric-Gynecologic
FMI Needle, Hypodermic, Single Lumen
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 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
0086196000306 1 00861916000306 In Commercial Distribution TRAY
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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
No
No CLOSE

Customer Contact

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1-800-830-9118
REGARDEZ@CORDSTICK.COM
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