AccessGUDID - DEVICE: AmeriWater Water Purification System for Hemodialysis (00817927020338)

GUDID

Device Identifier (DI) Information

Brand Name: AmeriWater Water Purification System for Hemodialysis
Version or Model: Complete System
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMERIWATER, LLC

Primary DI Number: 00817927020338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 836758342 *Terms of Use

Device Description: AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14437	Reverse-osmosis water purification system	An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991519	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant
Peracetic Acid
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f397fdc-4ac8-41ca-b433-5c4496bb481d
Public Version Date: June 15, 2023
Public Version Number: 1
DI Record Publish Date: June 07, 2023