Aquasence

Basic Information

• Brand Name: Aquasence
• Primary DI: 00754021215973
• Version / Model: 770-501
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-21
• Public Version: 2
• Public Version Date: 2020-06-02
• Public Version Status: Update
• Public Device Record Key: 2b59c2bd-4aaa-47ce-951a-1426a5e67bab
• Distribution End Date: 2019-06-21

Device Description

Bath SafetyBenches/Stools Product Description: AQS B.SEAT NO BK, WHITE, As. 2EA/CV

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• 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
ILS	ADAPTOR, HYGIENE	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41069	Bath back rest/seat	A device designed to support the back, and sometimes buttocks, of a patient (usually an adult) who is bathing in a bath (usually while being attended/assisted) to enable the patient to sit in an upright, and sometimes elevated, position in the bath. The patient is typically disabled, infirm, or undergoing medical treatment and cannot sit normally in a bath. The device may be a back rest only or a seat with an incorporated back rest, typically made of water-resistant or waterproof materials; it may be laid across the rim of the bath or secured to the bath. The device 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
Package	50754021215978	GS1		2	Not in Commercial Distribution	2019-06-21
Primary	00754021215973	GS1