FDA.reportPublic FDA data

Dual Nasal Hood For Anesthesia with LuerSafe CO2 Monitoring Single Use Large Van

Primary DI
05055788753599
Brand
Dual Nasal Hood For Anesthesia with LuerSafe CO2 Monitoring Single Use Large Van
Company
FLEXICARE MEDICAL LIMITED
Model
035-55-330VU
Published
2020-03-11
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
KHAMask, Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
KHAMask, ScavengingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788753599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788753599050557887535995055788753599

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia face mask, single-useA flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282299McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282312McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
09555866301385DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2026-04-02
10197344162550MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
10197344162567MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
09555866300869DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
10884389815311MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
10884389815069MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
10197344111107MEDLINEMEDLINE INDUSTRIES, INC.CCK2024-09-09
10841522126413TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCCK2024-07-16
10843997017685NomolineMASIMO CORPORATIONCCK2024-03-19
10620974003684Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2024-01-26
10620974003097Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003103Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003127Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003134Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003158Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003165Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003172Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003189Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003202Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003219Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003226Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003608Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003615Oxy2ProSouthmedic IncorporatedCCK2023-12-01