BioPure HX2

GUDID 00817492022393

MAR COR PURIFICATION, INC.

Reverse-osmosis water purification system
Primary Device ID00817492022393
NIH Device Record Key9fda80b5-a5c9-4fc4-b38d-1fdd756fbbef
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPure HX2
Version Model NumberHX2P-11811XX
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
Phone8002685035
Emailorderdesk@mcpur.com
Phone8002685035
Emailorderdesk@mcpur.com

Device Dimensions

Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound
Weight3234 Pound

Operating and Storage Conditions

Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817492022393 [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 Date2019-03-01
Device Publish Date2019-01-29

On-Brand Devices [BioPure HX2]

00817492022393HX2P-11811XX
00817492022386HX2P-05811XX
00817492022379HX2P-05811XX
00817492022362HX2P-05611XX
00817492022539RO/BIOPURE HX2P-11GPM/208V/3PH/60HZ/DL
00817492022522RO/BIOPURE HX2P-11GPM/460V/3PH/60HZ/DL

Trademark Results [BioPure HX2]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOPURE HX2
BIOPURE HX2
85602094 4795507 Live/Registered
Mar Cor Purification, Inc.
2012-04-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.