DEVICE: Medical Action Industries (10809160007334)

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Device Identifier (DI) Information

Medical Action Industries
57617E

MEDICAL ACTION INDUSTRIES INC.
10809160007334
GS1
1
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Vascular catheterization support kit A collection of sterile devices intended to support a central venous and/or aterial catheterization procedure, and/or ongoing vascular catheter maintanence. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintanence (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OWL Peripheral catheter insertion kit
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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
Special Storage Condition, Specify: store at room temperature
Special Storage Condition, Specify:
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

Not in Commercial Distribution
August 20, 2016
March 06, 2017
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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
20809160007331 20 10809160007334 2017-03-06 Not in Commercial Distribution
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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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Yes
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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No Customer Contact currently defined
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