Necessities Kit NK-01

GUDID 20813079022606

Cardio Kit Containing (1) 9Fr Single Hemostasis Valve, (1) 20GAx5" Insertion Tool and (1) 0.009 - 0.018" Guidewire Torque Device

REMINGTON MEDICAL, INC.

Angiography kit Angiography kit

• Primary Device ID: 20813079022606
• NIH Device Record Key: 691ec14d-5703-44ee-9a30-f7993b530003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Necessities Kit
• Version Model Number: NK-01
• Catalog Number: NK-01
• Company DUNS: 788472314
• Company Name: REMINGTON MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Catheter Gauge: 9 French
• Catheter Gauge: 9 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813079022602 [Primary]
GS1	10813079022609 [Package]; Contains: 00813079022602; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	20813079022606 [Package]; Contains: 10813079022609; Package: Shipping Carton [12 Units]; In Commercial Distribution

FDA Product Code

• OEQ: Angiography/angioplasty kit

Sterilization

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

[20813079022606]

Ethylene Oxide

[20813079022606]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-11
• Device Publish Date: 2018-11-10

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