Air Relax Classic Model AR-2.0 Control Unit Only

GUDID 08809040526813

Air Relax Classic Model AR-2.0 Control Unit Only (110V US PLUG - TYPE A)

Maxstar Industrial Co.,Ltd.

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Primary Device ID08809040526813
NIH Device Record Keybe0698de-43cd-46b2-9486-d19c36fb0c09
Commercial Distribution StatusIn Commercial Distribution
Brand NameAir Relax Classic Model AR-2.0 Control Unit Only
Version Model NumberAR2
Company DUNS687844027
Company NameMaxstar Industrial Co.,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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108809040526813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-28
Device Publish Date2021-07-20

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