Aqualine SID Suction Irrigation Device

Basic Information

• Brand Name: Aqualine SID Suction Irrigation Device
• Primary DI: 10862106000301
• Version / Model: S0004
• Company Name: CAPSTONE SURGICAL TECHNOLOGIES
• Labeler DUNS: 100435824
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-11
• Public Version: 6
• Public Version Date: 2020-08-25
• Public Version Status: Update
• Public Device Record Key: b9048742-3bb1-424e-975c-66abe46a6b88
• Distribution End Date: 2019-12-27

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60793	Surgical irrigation/aspiration handpiece, single-use	A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10862106000301	GS1
Package	20862106000308	GS1		6	Not in Commercial Distribution	2019-12-27

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius