DEVICE: Manan Medical Products, Inc. (00859013006109)

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Device Identifier (DI) Information

Manan Medical Products, Inc.
502502
502502
MANAN MEDICAL PRODUCTS, INC.
00859013006109
GS1
1
Vascular Access Needle 18GA.ETW X 2.75"
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Vascular catheter introduction needle A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DWS Instruments, Surgical, Cardiovascular
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 2.75 Inch
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Device Status

In Commercial Distribution
October 26, 2016

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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
20859013006103 3 10859013006106 In Commercial Distribution Unit Boxes
10859013006106 30 00859013006109 In Commercial Distribution Tyvek Pouch
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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

[?]
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

[?]
224-625-8331
David.Gasparik@argonmedical.com
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