BioPure 4400 RO

GUDID 00817492021884

Biolab Equipment Ltd

Reverse-osmosis water purification system
Primary Device ID00817492021884
NIH Device Record Key77650fd4-7ba6-4a64-bd07-c8323f9b70a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPure 4400 RO
Version Model Number42M18B2F
Company DUNS243149549
Company NameBiolab Equipment Ltd
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

Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 Pound
Weight506 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
GS100817492021884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FIPSubsystem, Water Purification

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-27
Device Publish Date2017-07-12

On-Brand Devices [BioPure 4400 RO]

0081749202191442M16BB2E
0081749202189122M16BB2F
0081749202188442M18B2F
0081749202187722M18B2F
0081749202186032M16BB2E
00817492021808RO/4400V/16000USGPD/TFC/230/3/60/5.5HP/Tank Feed
0081749202177832M10B2F
00817492021686125M16B2F
00817492021679125M16B2E
00817492021662122M16B2F
00817492021655122M16B2E
00817492021648105M16B2F
00817492021631105M16B2E
00817492021624102M16B2F
00817492021617102M16B2E
0081749202160095M16B2F
0081749202159495M16B2E
0081749202158792M16B2F
0081749202157092M16B2E
0081749202156385M16B2F
0081749202155685M16B2E
0081749202154982M16B2F
0081749202153282M16B2E
0081749202152565M16B2F
0081749202151865M16B2E
0081749202150162M16B2F
0081749202149562M16B2E
0081749202148855M16B2F
0081749202147155M16B2E
0081749202146452M16B2F
0081749202145752M16B2E
0081749202144045M16B2F
0081749202143345M16B2E
0081749202142642M16B2F
0081749202141942M16B2E
0081749202140235M16B2F
0081749202139635M16B2E
0081749202138932M16B2F
0081749202137232M16B2E
0081749202136525M16B2F
0081749202135825M16B2E
0081749202134122M16B2F
0081749202133422M16B2E

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