Manan Medical Products, Inc. GWI20015EWW

GUDID 20859013006189

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

MANAN MEDICAL PRODUCTS, INC.

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• Primary Device ID: 20859013006189
• NIH Device Record Key: 9fb29abb-be35-433b-b1d1-c18621bc2763
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manan Medical Products, Inc.
• Version Model Number: GWI20015EWW
• Catalog Number: GWI20015EWW
• Company DUNS: 831737957
• Company Name: MANAN MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com
• Phone: 224-625-8331
• Email: David.Gasparik@argonmedical.com

Device Dimensions

• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch
• Length: 1.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859013006185 [Primary]
GS1	10859013006182 [Package]; Contains: 00859013006185; Package: Tyvek Pouch [10 Units]; In Commercial Distribution
GS1	20859013006189 [Package]; Contains: 10859013006182; Package: Unit Boxes [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851834

FDA Product Code

• DWS: Instruments, Surgical, Cardiovascular

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

[20859013006189]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-26

On-Brand Devices [Manan Medical Products, Inc.]

• 20859013006189: Guide Wire Introducer Needle With Window Wall Hub 20GA X 1.5"
• 20859013006172: Guide Wire Introducer Needle With Window Wall Hub 18GA.ETW X 2.75"
• 20859013006165: 18GA.ETW X 2.75" Guide Wire Introducer Needle
• 20859013006158: Winged Access Needle 18GA.ETW X 2.75"
• 20859013006141: Two Part Modified Cournand Needle 18GA.ETW X 2.25"
• 20859013006134: Two Part Seldinger Access Needle 18GA.ETW X 2.875"
• 20859013006127: Vascular Access Needle 21GA.TW X 1.5"
• 20859013006110: Vascular Access Needle 19GA.SP x 2.75"
• 20859013006103: Vascular Access Needle 18GA.ETW X 2.75"