DEVICE: Manan Medical Products, Inc. (00859013006154)

Device Identifier (DI) Information

Manan Medical Products, Inc.
502652
Not in Commercial Distribution
502652
MANAN MEDICAL PRODUCTS, INC.
00859013006154
GS1
March 11, 2019
1
831737957 *Terms of Use
Winged 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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61502 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWS Instruments, Surgical, Cardiovascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K851834 000
No CLOSE

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 Record Status

f6233f12-7f3b-4ad2-af74-1418a3432d4d
July 19, 2021
4
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
20859013006158 3 10859013006151 2019-03-11 Not in Commercial Distribution Unit Boxes
10859013006151 30 00859013006154 2019-03-11 Not in Commercial Distribution Tyvek Pouch
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Secondary DI

[?]
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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