FDA.reportPublic FDA data

MedSource Sampling Cannula

Primary DI
00840155413061
Brand
MedSource Sampling Cannula
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-35400A7
Catalog number
Not Applicable
Device description
7’ Adult Nasal CO2 Sampling Cannula
Published
2022-05-24
Public version status
Update
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
00840155413078PackageGS125In Commercial Distribution
00840155413085PackageGS1200In Commercial Distribution
00840155413061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155413078008401554130788401554130780840155413078
00840155413085008401554130858401554130850840155413085
00840155413061008401554130618401554130610840155413061

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide breath analyser, home-useAn electrically-powered device intended to be used in a clinical setting and in the home to measure the concentration of exhaled carbon dioxide (CO2) in normal tidal breathing, using a particular method (e.g., infrared spectroscopy, gas chromatography), and to telemetrically send data to a remote server and/or local computer/tablet for viewing results and clinical evaluation by a healthcare professional. It consists of a hand-held sensor unit and might in addition include a replaceable breath sampling chamber and a breathing mouthpiece. It is used to help identify or assess cardio-respiratory conditions (e.g., chronic obstructive pulmonary disease, asthma, chronic heart failure).

Regulatory Flags#

DUNS number
041674552
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840155408425MedSource BlanketMS-40521Not Applicable2021-07-07
00816703023617MedSource First Aid KitNORTH-349000Not Applicable2021-08-17
00816703023723MedSource BagsNORTH-678805EMNot Applicable2021-08-17
00816703023839MedSource First Aid WalletNORTH-67M08Not Applicable2021-08-25
00816703024034MedSource Packed BagsSH-B1311Not Applicable2021-08-25
00840155404304MedSource Body BagsMS-BOD200Not Applicable2021-07-28
00840155406094MedSource Emergency BlanketMS-B100Not Applicable2021-07-27
00840155406162MedSource Emergency BlanketMS-B200Not Applicable2021-07-27
00816703023853MedSource BagsNORTH-67M09Not Applicable2021-08-25
00816703023860MedSource BagsNORTH-67M10Not Applicable2021-08-25
00816703023938MedSource Packed BagsNORTH-90LGTRAUMNot Applicable2021-08-25
00816703023952MedSource Packed BagsNORTH-90TRAUMAENot Applicable2021-08-25
00816703024058MedSource First Aid KitSH-B1411Not Applicable2021-08-25
00816703024065MedSource Packed BagsSH-B1412Not Applicable2021-08-25
00816703027097MedSource BagsMS-TLS-3-BNot Applicable2021-08-16
00816703029473MedSource BagsMS-33360-RCSNot Applicable2021-08-03
00840155404540MedSource BagsMS-B33655FPNot Applicable2021-07-28
00840155404670MedSource BagsMS-B3362Not Applicable2021-07-28
00840155407411MedSource BagsMS-B3350RNot Applicable2021-07-28
00840155406667MedSource BagsMS-B3309Not Applicable2021-07-27

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