Necessities Kit

Basic Information

• Brand Name: Necessities Kit
• Primary DI: 00813079022602
• Version / Model: NK-01
• Catalog Number: NK-01
• Company Name: REMINGTON MEDICAL, INC.
• Labeler DUNS: 788472314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-10
• Public Version: 1
• Public Version Date: 2018-12-11
• Public Version Status: New
• Public Device Record Key: 691ec14d-5703-44ee-9a30-f7993b530003

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEQ	Angiography/angioplasty kit	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16545	Angiography kit	A collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20813079022606	GS1	Shipping Carton	12	In Commercial Distribution
Package	10813079022609	GS1	Inner Carton	10	In Commercial Distribution
Primary	00813079022602	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	9	French