Aquatec Ocean Ergo Pail Support Guide Rail-

Basic Information

• Brand Name: Aquatec Ocean Ergo Pail Support Guide Rail-
• Primary DI: 04028698132755
• Version / Model: AP1602078
• Catalog Number: AP1602078
• Company Name: INVACARE CORPORATION
• Labeler DUNS: 076916246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-22
• Public Version: 1
• Public Version Date: 2019-12-02
• Public Version Status: New
• Public Device Record Key: 5caa95c4-1adc-4741-96dc-fd3453b18bbd

Device Description

Aquatec Ocean Ergo Pail Support Guide Rail

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
INN	CHAIR, ADJUSTABLE, MECHANICAL	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34936	Shower seat, non-powered	A non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04028698132755	GS1

Customer Contacts

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