FDA.reportPublic FDA data

Salter ETCo2/O2 Cannula

Primary DI
10889483610954
Brand
Salter ETCo2/O2 Cannula
Company
SALTER LABS
Model
4MSF1SOFT-7-6
Device description
Adult. O2/ETCO2 Filtered Oral/Nasal Divided Soft Cannula, 7' O2 line, 6' ETCO2 line
Published
2024-03-31
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
K151421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151421000Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs2016-03-10CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483610958PackageGS125In Commercial Distribution
10889483610954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948361095830889483610958
1088948361095410889483610954

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.

Regulatory Flags#

DUNS number
022721133
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
00607411000737N/A8900-148900-142016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
00607411700002N/A7100-07100-02016-09-24
00607411700040N/A7600-07600-02016-09-24
00607411700057N/A7900-07900-02016-09-24
00607411889349N/ASO-1818-0SO-1818-02016-09-24
00607411889912n/aSO-1840-0SO-1840-02016-11-30
00607411890031N/A8900-78900-72016-09-24
00607411890055N/A8900TG-78900TG-72016-09-24
00607411890062N/A8901-08901-02016-09-24
00607411890079N/A8902-78902-72016-09-24
00607411890116N/A8905-08905-02016-09-24
00607411890123N/A8906-78906-72016-09-24
00607411890147n/a8910-08910-02016-11-30
00607411890154N/A8911-78911-72016-09-24
00607411890253N/A8924-78924-72016-09-24
00607411890260N/A8924TG-78924TG-72016-09-24

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