AquaBplus & AquaBplus HF

GUDID 04251285200166

The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substanc

VIVONIC GmbH

Reverse-osmosis water purification system
Primary Device ID04251285200166
NIH Device Record Key8e21d0b9-1f99-415c-9f34-aa7b0b5f5ebf
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquaBplus & AquaBplus HF
Version Model Number2500
Company DUNS341685795
Company NameVIVONIC GmbH
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104251285200166 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [AquaBplus & AquaBplus HF]

04251285200173The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
04251285200166The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
04251285200159The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
04251285200142The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
04251285200135The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia
04251285200128The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia

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