ORI Airways

GUDID 10860011532740

Focal Point Logistics, LLC

Nasal oxygen cannula, carbon-dioxide-sampling
Primary Device ID10860011532740
NIH Device Record Keye0152aff-4723-4614-8f91-b42fb641229e
Commercial Distribution StatusIn Commercial Distribution
Brand NameORI Airways
Version Model NumberDM-4000-14FTAF
Company DUNS129992866
Company NameFocal Point Logistics, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com
Phone9726380496
Emailinfofocalpoint@icloud.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011532743 [Primary]
GS110860011532740 [Package]
Contains: 00860011532743
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-23
Device Publish Date2024-07-15

On-Brand Devices [ORI Airways]

10860011532795Sampling cannula, no oxygen delivery.
10860011532788DM-4100-AF
10860011532771DM-7700-ST
10860011532764DM-7100/CO-8FTM
10860011532757DM-4000-14FTAM
10860011532740DM-4000-14FTAF
10860011532733DM-4000-AF
10860011532726DM-4000-10FTAF
10860011532719DM-4000-AM
10860011532702DM-4000-10FTAM

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