Manan Medical Products, Inc. 502652

GUDID 20859013006158

Winged Access Needle 18GA.ETW X 2.75"

MANAN MEDICAL PRODUCTS, INC.

Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle Vascular catheter introduction needle

• Primary Device ID: 20859013006158
• NIH Device Record Key: f6233f12-7f3b-4ad2-af74-1418a3432d4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Manan Medical Products, Inc.
• Version Model Number: 502652
• Catalog Number: 502652
• 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: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch
• Length: 2.75 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859013006154 [Primary]
GS1	10859013006151 [Package]; Contains: 00859013006154; Package: Tyvek Pouch [30 Units]; In Commercial Distribution
GS1	20859013006158 [Package]; Contains: 10859013006151; Package: Unit Boxes [3 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

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

Ethylene Oxide

[20859013006158]

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.]

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• 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"