FDA.reportPublic FDA data

Mindray Cannula

Primary DI
10889483555057
Brand
Mindray Cannula
Company
SALTER LABS
Model
SO-2180
Catalog number
4703
Device description
Mindray Pediatric EtCO2-O2 Nasal Divided Cannula
Published
2024-07-05
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
30889483555068PackageGS125In Commercial Distribution
10889483555057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948355506830889483555068
1088948355505710889483555057

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
Serial number
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
00607411201509Salter Labs Adult, ETC02 Nasal Sampling Cannula, female luer style connecSO-165090122016-09-24
00607411001147AirLife1007-01007-0-102016-11-30
00607411001154AirLife1008-01008-0-102016-11-30
00607411001024AirLife1005-01005-0-252016-11-30
10607411001045AirLife1016-0-251016-0-252016-11-30
10607411891714AirLife1017-0-251017-0-252016-11-30
10607411001038AirLife1006-0-1001006-0-1002016-11-30
10607411891110AirLife1217-0-251217-0-252016-11-30
00607411001048AirLife1016-01016-02019-04-29
00607411919039Salter Labs® High Concentration partial rebreather131202026-06-10
00607411919077Salter Labs® Nasal Cannula133002026-06-10
00607411919091Salter Labs® Nasal Cannula133042026-06-10
00607411919121Salter Labs® Nasal Cannula133092026-06-10
00607411919190Salter Labs® Nasal Cannula133372026-06-10
00607411919213Salter Labs® Nasal Cannula133472026-06-10
00607411919268Salter Labs® Oxygen Tubing134092026-06-10
00607411919282Oxygen Tubing Swivel Connector134452026-06-10
00607411919336Salter Labs® Percent-O2-Lock® Mask138152026-06-10
00607411919343Salter Labs® Full Kit Nebulizer139502026-06-10
00607411919367Salter Labs® Full Kit Nebulizer Set139522026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00607411919190Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919213Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919206MedTronic ETCo2 CannulaSALTER LABSCCK2026-06-09
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14