BioPure Portable RO

GUDID 00817492021907

Biolab Equipment Ltd

Reverse-osmosis water purification system
Primary Device ID00817492021907
NIH Device Record Key17e1a0a9-2042-47f2-8b19-53ba732810f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPure Portable RO
Version Model Number2615A2RO
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

Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound
Weight140 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817492021907 [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 Date2017-09-28

On-Brand Devices [BioPure Portable RO]

008174920219072615A2RO
008174920213272612A2RO

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