Irrigation Set

Basic Information

• Brand Name: Irrigation Set
• Primary DI: 10887787006732
• Version / Model: 654401
• Catalog Number: 0654401
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• Labeler DUNS: 830767898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-31
• Public Version: 2
• Public Version Date: 2019-01-23
• Public Version Status: Update
• Public Device Record Key: d90797cd-caf6-4697-a9d9-080f943e088a

Device Description

LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation For Use with Flexible Irrigation Container System (previously Hospira product)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBX	CATHETER, IRRIGATION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58752	Arthroscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20887787006739	GS1	case	20	In Commercial Distribution
Primary	10887787006732	GS1
Secondary	M3356544010	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	77	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature. Avoid Excessive Heat. Protect from Freezing