FDA.reportPublic FDA data

ORI Airways

Primary DI
00860011532736
Brand
ORI Airways
Company
Focal Point Logistics, LLC
Model
DM-4000-AF
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143127000CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only styleDispo-Med (Malaysia) Sdn Bhd2015-02-13CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860011532733PackageGS125In Commercial Distribution
00860011532736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001153273310860011532733
00860011532736008600115327368600115327360860011532736

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
9726380496infofocalpoint@icloud.com

Regulatory Flags#

DUNS number
129992866
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011532705ORI Airways DM-4000-10FTAM2024-07-15
00860011532712ORI AirwaysDM-4000-AM2024-07-15
00860011532729ORI AirwaysDM-4000-10FTAF2024-07-15
00860011532743ORI AirwaysDM-4000-14FTAF2024-07-15
00860011532750ORI AirwaysDM-4000-14FTAM2024-07-15
00860011532767ORI AirwaysDM-7100/CO-8FTM2024-07-15
00860011532774ORI AirwaysDM-7700-ST2024-07-15
00860011532781ORI AirwaysDM-4100-AF2024-07-15
00860011532798ORI AirwaysDM-4100-AM2024-07-15
10860011532702ORI Airways DM-4000-10FTAM2024-07-15
10860011532719ORI AirwaysDM-4000-AM2024-07-15
10860011532726ORI AirwaysDM-4000-10FTAF2024-07-15
10860011532733ORI AirwaysDM-4000-AF 2024-07-15
10860011532740ORI AirwaysDM-4000-14FTAF2024-07-15
10860011532757ORI AirwaysDM-4000-14FTAM2024-07-15
10860011532764ORI AirwaysDM-7100/CO-8FTM2024-07-15
10860011532771ORI AirwaysDM-7700-ST2024-07-15
10860011532788ORI AirwaysDM-4100-AF2024-07-15
10860011532795ORI AirwaysDM-4100-AM2024-07-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521858107NellcorCovidien LPCCK2026-05-29
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