Disposable Tear-Away Vascular Introducer Set 7008

GUDID 10813079020186

1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire

REMINGTON MEDICAL, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10813079020186
• NIH Device Record Key: 8714cc7d-9c79-4fac-8727-02be4def2e8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Tear-Away Vascular Introducer Set
• Version Model Number: 7008
• Catalog Number: 7008
• Company DUNS: 788472314
• Company Name: REMINGTON MEDICAL, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com
• Phone: +1(800)989-0057
• Email: Quality@Remmed.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079020189 [Primary]
GS1	10813079020186 [Package]; Contains: 00813079020189; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	20813079020183 [Package]; Package: Shipping Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932370

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

[10813079020186]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-11-10

On-Brand Devices [Disposable Tear-Away Vascular Introducer Set]

• 20813079020213: 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
• 10813079020209: 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
• 20813079020190: 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
• 10813079020186: 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
• 10813079020179: 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038
• 10813079020162: 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038