FDA.reportPublic FDA data

ORI Airways

Primary DI
10860011532771
Brand
ORI Airways
Company
Focal Point Logistics, LLC
Model
DM-7700-ST
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10860011532771PackageGS125In Commercial Distribution
00860011532774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001153277110860011532771
00860011532774008600115327748600115327740860011532774

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9726380496infofocalpoint@icloud.com

Regulatory Flags#

DUNS number
129992866
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00860011532736ORI AirwaysDM-4000-AF 2024-07-15
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
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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