DEVICE: Manan Medical Products, Inc. (00859013006154)
Device Identifier (DI) Information
Manan Medical Products, Inc.
502652
Not in Commercial Distribution
502652
MANAN MEDICAL PRODUCTS, INC.
502652
Not in Commercial Distribution
502652
MANAN MEDICAL PRODUCTS, INC.
Winged Access Needle
18GA.ETW X 2.75"
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWS | Instruments, Surgical, Cardiovascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K851834 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 2.75 Inch |
Device Record Status
f6233f12-7f3b-4ad2-af74-1418a3432d4d
July 19, 2021
4
October 26, 2016
July 19, 2021
4
October 26, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
224-625-8331
David.Gasparik@argonmedical.com
David.Gasparik@argonmedical.com