FreeStyle Comfort

GUDID M766AS2001DTC0

Portable Oxygen Concentrator, 1-5 LPM, Pulse Dose Setting, English All Accessory Bag

CAIRE INC.

Mobile/portable oxygen concentrator
Primary Device IDM766AS2001DTC0
NIH Device Record Key0d084904-d477-4488-a8d0-7535909054e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle Comfort
Version Model NumberAS200-1DTC
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
HIBCCM766AS2001DTC0 [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 Date2018-02-16

On-Brand Devices [FreeStyle Comfort]

M766AS2002010Portable Oxygen Concentrator, 1-5 LPM, Pulse Dose Setting, English Two Single Batteries
M766AS2001DTC0Portable Oxygen Concentrator, 1-5 LPM, Pulse Dose Setting, English All Accessory Bag
M766AS2001010Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Double Battery
M766AS20010Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Single Battery

Trademark Results [FreeStyle Comfort]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREESTYLE COMFORT
FREESTYLE COMFORT
90106110 not registered Live/Pending
CAIRE INC.
2020-08-11

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