OxyArm™ OA-DA-1025

GUDID 00620974000020

OxyArm Disposable Diffuser Arm

Southmedic Incorporated

Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask Vortex oxygen face mask
Primary Device ID00620974000020
NIH Device Record Keya34d3efe-3836-40bf-a825-d2f1457e8606
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxyArm™
Version Model NumberOA-DA-1025
Catalog NumberOA-DA-1025
Company DUNS246848147
Company NameSouthmedic Incorporated
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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

Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com
Phone+1(705)726-9383
Emailcustserv@southmedic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100620974000020 [Unit of Use]
GS110620974000027 [Primary]

FDA Product Code

BYGMASK, OXYGEN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-28
Device Publish Date2020-12-18

On-Brand Devices [OxyArm™]

10620974000034OxyArm ETCO2 Disposable Diffuser Arm
00620974000099OxyArm Plus Clear Adjustable Head Band with Nasal Cannula Arm and 7' tubing
00620974000075OxyArm Plus Clear Adjustable Head Band with Diffuser Arm with 7' tubing
00620974000051OxyArm Plus Clear Adjustable Head Band
00620974000044OxyArm Disposable Cannula Arm
00620974000020OxyArm Disposable Diffuser Arm

Trademark Results [OxyArm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OXYARM
OXYARM
76126759 2595617 Live/Registered
Southmedic Incorporated
2000-09-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.