DEVICE: Medical Action Industries (10809160126219)

Device Identifier (DI) Information

Medical Action Industries
80660B
In Commercial Distribution

MEDICAL ACTION INDUSTRIES INC.
10809160126219
GS1

1
092364462 *Terms of Use
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 catheter flush/disinfection kit A collection of sterile devices intended to be used to wash the lumen of a vascular access catheter and to disinfect the catheter’s Luer access valve in situ. It consists of a prefilled syringe containing a saline solution, and a disinfection cap containing a foam material saturated with disinfectant [e.g., isopropyl alcohol (IPA)]. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OFF Central venous catheter tray
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify:
Special Storage Condition, Specify: STORE AT ROOM TEMPERATURE
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Clinically Relevant Size

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

846d8e0b-4fb9-4d3b-8f5a-0220e4787fb6
March 29, 2018
2
February 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
20809160126216 20 10809160126219 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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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