Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002019232
• Version / Model: G01923
• Catalog Number: C-PMSY-300-RA
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-08-10
• Public Version Status: Update
• Public Device Record Key: af76ad29-9941-4c6f-8011-59d2f440649b

Device Description

Radial Artery Catheter Tray Polyethylene Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQY	CATHETER, PERCUTANEOUS	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65028	Peripheral artery catheterization kit, medicated	A collection of devices intended for the percutaneous introduction of an included peripheral artery cannula (often referred to as a catheter) to enable short-term (= 30 days) access to a peripheral artery for administration of fluids/medication and blood sampling. In addition to the cannula, it includes the pharmaceutical anaesthetic agent, devices dedicated to catheter introduction/function (e.g., introducer, guidewire, syringe), and non-dedicated devices intended to support the procedure [e.g., disinfectant (e.g., alcohol), drape, gauze, scalpel, suture, swabs]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002019232	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.