AccessGUDID - DEVICE: Manan Medical Products, Inc. (00859013006185)

GUDID

Device Identifier (DI) Information

Brand Name: Manan Medical Products, Inc.
Version or Model: GWI20015EWW
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GWI20015EWW
Company Name: MANAN MEDICAL PRODUCTS, INC.

Primary DI Number: 00859013006185
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 831737957 *Terms of Use

Device Description: Guide Wire Introducer Needle With Window Wall Hub 20GA X 1.5"

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 1.5 Inch

Device Record Status

Public Device Record Key: 9fb29abb-be35-433b-b1d1-c18621bc2763
Public Version Date: July 19, 2021
Public Version Number: 4
DI Record Publish Date: 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
20859013006189	10	10859013006182	2019-03-02	Not in Commercial Distribution	Unit Boxes
10859013006182	10	00859013006185	2019-03-02	Not in Commercial Distribution	Tyvek Pouch