BioPure 4400 RO

GUDID 00817492022089

MAR COR PURIFICATION, INC.

Reverse-osmosis water purification system
Primary Device ID00817492022089
NIH Device Record Key9c5f2b1c-8b92-465c-b1bb-9aeb682578e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPure 4400 RO
Version Model Number25M16B2F
Company DUNS019056181
Company NameMAR COR PURIFICATION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8002685035
Emailorderdesk@mcpur.com

Device Dimensions

Weight438 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817492022089 [Primary]

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-04
Device Publish Date2019-01-30

On-Brand Devices [BioPure 4400 RO]

0081749202228782M16B2F
0081749202206522M16B2E
0081749202205822M18B2F
0081749202204122M16BB2F
00817492022034125M16B2F
00817492022027125M16B2E
00817492022010122M16B2E
00817492022003122M16B2E
00817492021990105M16B2E
00817492021983105M16B2E
00817492021976102M16B2E
00817492021969https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
0081749202195222M16B2F
0081749202194562M16B2F
0081749202193842M16B2F
0081749202235595M16B2F
0081749202234895M16B2E
0081749202233192M16B2F
0081749202232492M16B2E
0081749202231785M16B2F
0081749202230085M16B2E
00817492022294RO/4400V/16000USGPD/TFC/230/3/60/5.5HP/Tank Feed
0081749202227082M16B2E
0081749202226365M16B2F
0081749202225665M16B2E
0081749202224962M16B2E
0081749202223255M16B2F
0081749202222555M16B2E
0081749202221852M16B2F
0081749202220152M16B2E
0081749202219545M16B2F
0081749202218845M16B2E
0081749202217142M18B2F
0081749202216442M16BB2E
0081749202215742M16B2E
0081749202214035M16B2F
0081749202213335M16B2E
0081749202212632M16BB2E
0081749202211932M16B2F
0081749202210232M16B2E
0081749202209632M10B2F
0081749202208925M16B2F
0081749202207225M16B2E
00817492022553RO, 4400M-12K, 208V, 1PH, 60HZ, 75% RCV, ST (4400M-12K RO Machine, 12,000 GPD, 208Volts, 1-Phase

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