AccessGUDID - DEVICE: BioPure 4400 RO (00817492022553)

GUDID

Device Identifier (DI) Information

Brand Name: BioPure 4400 RO
Version or Model: 62M12B-2F
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAR COR PURIFICATION, INC.

Primary DI Number: 00817492022553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 019056181 *Terms of Use

Device Description: RO, 4400M-12K, 208V, 1PH, 60HZ, 75% RCV, ST (4400M-12K RO Machine, 12,000 GPD, 208Volts, 1-Phase, 60 Hertz, 75% Recovery, Storage Tank)

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 [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: more than 32 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 627 Pound
Height: 80.5 Inch
Depth: 29 Inch
Width: 38 Inch

Device Record Status

Public Device Record Key: 0b68ec51-ff07-4f60-901c-a695af5af6c6
Public Version Date: October 21, 2021
Public Version Number: 1
DI Record Publish Date: October 13, 2021