Custom Procedure Kit

Basic Information

• Brand Name: Custom Procedure Kit
• Primary DI: 40677964028043
• Version / Model: 4005617
• Catalog Number: 4005617
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-16
• Public Version: 1
• Public Version Date: 2022-06-24
• Public Version Status: New
• Public Device Record Key: 44497282-b60b-4258-890a-48b73bd0be94

Device Description

Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Cylindrical Sponge, 5-piece Olympus DCA Kit, Under Pad, Gauze Pads, Slip Syringe Non-sterile, and Biohazard Sticker

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NWU	Endoscope introducer kit	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61950	Endoscopy preparation kit	A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40677964028050	GS1	Box	12	In Commercial Distribution
Primary	40677964028043	GS1

Customer Contacts

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