FREESTYLE

GUDID M766AS0951010

CAIRE INC.

Mobile/portable oxygen concentrator
Primary Device IDM766AS0951010
NIH Device Record Key53597d04-47b7-4df8-a02f-f197289ffccd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREESTYLE
Version Model NumberAS095-101
Company DUNS807537683
Company NameCAIRE INC.
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM766AS0951010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2016-06-30

On-Brand Devices [FREESTYLE]

M766AS0951U0FREESTYLE OXYGEN CONCENTRATOR, 1-3LPM, REFURBISHED
M766AS0951CU0FREESTYLE OXYGEN CONCENTRATOR, 1-3LPM, REFURBISHED
M766AS0951010AS095-101
M766AS09510FREESTYLE OXYGEN CONCENTRATOR, 1-3LPM
M766AS0771010AS077-101

Trademark Results [FREESTYLE]

Mark Image

Registration | Serial
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Trademark
Application Date
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2022-09-21
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2021-11-04
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2021-11-01
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2021-09-08
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2020-10-21
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2021-07-28
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2021-07-28
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90764538 not registered Live/Pending
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2021-06-09

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