Device
Part Number 106610, ROSI with Wings,Tubing Set
Manufacturer
VASCULAR TECHNOLOGY, INCORPORATED
Model: 106610 Catalog: 106610 DI: 00817122020607 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-12 Current Version: 2026-05-20
Description
Part Number 106610, ROSI with Wings,Tubing Set
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: a72b1247-b9fa-4151-ad4c-b73e9ff0df17
Distribution Status: In Commercial Distribution
DUNS Number: 161989343
Device Count: 4
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Item #1 - Device ID: 00817122020591
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00817122020607
Item #2 - Device ID Type: Primary
Item #2 - 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
GCJ
Laparoscope, general & plastic surgery
Premarket Submissions
Submission Number: K141323
Supplement Number: 000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit: Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value: -30
Item #1 - Storage Handling High - @attributes - Unit: Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value: 60
Item #1 - Storage Handling Type: Storage Environment Temperature
Item #2 - Storage Handling Type: Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text: Keep Dry