BioPure Portable RO

GUDID 00817492021327

Biolab Equipment Ltd

Reverse-osmosis water purification system
Primary Device ID00817492021327
NIH Device Record Keycb08a2e7-9c60-43d7-8ed8-0f20124181e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioPure Portable RO
Version Model Number2612A2RO
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

Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch
Width12.5 Inch

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
GS100817492021327 [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 Date2016-09-23

On-Brand Devices [BioPure Portable RO]

008174920219072615A2RO
008174920213272612A2RO

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