FDA.reportPublic FDA data

DUAL NARE NASAL CANNULAE MALE LUER CON 10FT O2 TUBE

Primary DI
05055788755456
Brand
DUAL NARE NASAL CANNULAE MALE LUER CON 10FT O2 TUBE
Company
FLEXICARE MEDICAL LIMITED
Model
032-10-127U
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05055788755456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788755456050557887554565055788755456

GMDN Terms#

Term, Definition table
TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27
05055931102090Maxineb Duo Nebulizer + Mouthpiece And Tubing032-10-038U2020-03-27
05055931102113Maxineb Duo Nebulizer + Mouthpiece, Tubing And Filter032-10-039U2020-03-27

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Primary DI, Brand, Company table
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