AccessGUDID - DEVICE: Acidified Concentrate Distribution and Storage (ACDS) System (00852456007092)

GUDID

Device Identifier (DI) Information

Brand Name: Acidified Concentrate Distribution and Storage (ACDS) System
Version or Model: MD704262
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Isopure, Corp.

Primary DI Number: 00852456007092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040279650 *Terms of Use

Device Description: Acidified Concentrate Distribution and Storage System (ACDS System)

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):	No
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?
36342	Haemodialysis system fluid mixer	An electrically-powered integral unit of a haemodialysis system that mixes a concentrate and water to the dialysis solution (dialysate) and monitors the mixture.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120005	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: f359f2ba-1fa4-4dcd-8200-3bd9236ba029
Public Version Date: August 31, 2023
Public Version Number: 4
DI Record Publish Date: September 20, 2017