AmeriWater 00BCMD55

Basic Information

• Brand Name: AmeriWater 00BCMD55
• Primary DI: 00817927020307
• Version / Model: 00BCMD55
• Company Name: AMERIWATER, LLC
• Labeler DUNS: 836758342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-10
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 3bab56dd-b1bc-41dd-b0c1-add226637f74

Device Description

00BCMD55 Single Tank Mix and Distribution Bicarb, 55 Gallon

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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: Yes
• Sterilization Methods: ["Liquid Chemical", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FIN	Tank, Holding, Dialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36345	Haemodialysis bicarbonate solution preparation mixer	An electrically-powered unit intended to mix a bicarbonate concentrate(s), commonly in powder form, with water to produce a bicarbonate haemodialysis solution. It typically includes tanks with connection hoses, controls and display; some types may include solution delivery features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817927020307	GS1

Premarket Submissions

Submission Number	Supplement Number
K051031	000

Device Sizes

Type	Value	Unit	Text
Width	43	Inch
Depth	31	Inch
Height	55	Inch
Weight	160	Pound