FMS

Basic Information

• Brand Name: FMS
• Primary DI: 10886705023233
• Version / Model: 284649
• Catalog Number: 284649
• Company Name: DEPUY MITEK, LLC
• Labeler DUNS: 190572854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 5
• Public Version Date: 2019-04-23
• Public Version Status: Update
• Public Device Record Key: a08c9beb-53d2-4c96-8702-fddb2958f4f0

Device Description

FMS Fluid Management System Outflow Tubing with One-Way valve (FMS VUE or FMS DUO Plus)

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
HRX	ARTHROSCOPE	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886705023230	GS1	PACKAGE	24	In Commercial Distribution
Primary	10886705023233	GS1
Package	30886705023237	GS1	BOX	12	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K951843	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Pallet 2 Stacked
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit