FDA.reportPublic FDA data

Flexicare

Primary DI
05055931101024
Brand
Flexicare
Company
FLEXICARE MEDICAL LIMITED
Model
032-10-180/1U
Device description
Dual Adult Oral Nasal Cannula 7ft O2 Delivery/CO2 Monitoring, Filter, Microstream Luer, M-M Adapter
Published
2024-03-05
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
CATCannula, Nasal, Oxygen
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140113000O2 NASAL CANNULA WITH CO2 MONITORINGFlexicare Medical, Ltd.2014-03-06CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055931101024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055931101024050559311010245055931101024

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

Regulatory Flags#

DUNS number
504406273
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055931134763Flexicare038-61-319U038-61-319U2026-10-09
05055931133858Reusable Angle Connector for CBS Bag Arm – Male to Male6002207-012026-07-21
05055931133865Reusable Angle Connector for CBS Bag Arm – Male to Female6002207-022026-07-21
05055788767640Leg Bag Holder Extra Large00-0038U2020-03-25
05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767701Leg Bag Holder Medium00-0036U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
05055788787143Flexicare040-12-2140U2026-03-31
05055788791317Flexicare030-620/1U2024-03-13
05055931101963Maxineb Duo Filter Pad032-10-021U2020-03-27
05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
00818834029049CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029063CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029087CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029100CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029124CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029148CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029162CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029186CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
10885403531521BD Alaris™ ETCO2 Module Model 8300CAREFUSION 303, INC.CCK2026-10-08
00607411917332Salter LabsSALTER LABSCAT2026-10-07
00607411917363Salter LabsSALTER LABSCAT2026-10-07
00607411917394Salter LabsSALTER LABSCAT2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyCCK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyCCK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyCCK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyCCK2026-10-04
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26
10889483618288Air LifeAIRLIFECCK2026-08-26
10889483618295Air LifeAIRLIFECCK2026-08-26
10889483618301Air LifeAIRLIFECCK2026-08-26
10889483618318Air LifeAIRLIFECCK2026-08-26
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