FDA.reportPublic FDA data

Philips MR Patient Care LoFlo Cannula Line

Primary DI
00607411982040
Brand
Philips MR Patient Care LoFlo Cannula Line
Company
SALTER LABS
Model
P183281
Catalog number
989803183281
Device description
MR Oatient Care Pediatric LoFlo CO/O2 Cannula
Published
2023-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
10607411982047PackageGS120In Commercial Distribution
00607411982040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741198204710607411982047
00607411982040006074119820406074119820400607411982040

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
00607411919008Salter Labs® Adult Comfort Face Tent131032026-06-09
00607411919053Salter Labs® Oxygen Mask131242026-06-09
00607411919060Salter Labs® Oxygen Mask131252026-06-09
00607411919084MedTronic Cannula133012026-06-09
00607411919107Salter Labs® Nasal Cannula133072026-06-09
00607411919138Salter Labs® Nasal Cannula133102026-06-09
00607411919206MedTronic ETCo2 Cannula133402026-06-09
00607411919220Salter Labs® Oxygen Tubing134002026-06-09
00607411919237Salter Labs® Oxygen Tubing134042026-06-09
00607411919244Salter Labs® Oxygen Tubing134072026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)134082026-06-09
00607411919299MedTronic NebuTech135002026-06-09
00607411919329Salter Labs® NebuTech®135062026-06-09
00607411919350Salter Labs® Full Kit Nebulizer139512026-06-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919206MedTronic ETCo2 CannulaSALTER LABSCCK2026-06-09
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282213McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282237McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14