Device
Suction cartridge and tubing
Manufacturer
Auris Health, Inc.
Model: MUR-000017 Catalog: MUR-000017 DI: 10810068811114 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-05 Current Version: 2026-05-13
Description
Suction cartridge and tubing
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: bc99166f-df35-42eb-a475-5e2dea206a4e
Distribution Status: In Commercial Distribution
DUNS Number: 015823456
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: Yes
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Device ID: 10810068811114
Item #1 - Device ID Type: Primary
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Pkg Type: Inner Shelf Box
Item #2 - Device ID: 20810068811111
Item #2 - Pkg Status: In Commercial Distribution
Item #2 - Pkg Quantity: 1
Item #2 - Device ID Type: Package
Item #2 - Contains DINumber: 10810068811114
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Shipper Box
Item #3 - Device ID: 30810068811118
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 5
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 20810068811111
Item #3 - Device ID Issuing Agency: GS1
GMDN
Code: 47625
Name: Surgical irrigation/aspiration tubing set
Definition:
A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). 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.
FDA Product Codes
FGA
Kit, Nephroscope
Premarket Submissions
Submission Number: K213334
Supplement Number: 000