FDA.reportPublic FDA data

Pressure Relief Valve For High Flow Oxygen Therapy 40cmH20

Primary DI
05055788702115
Brand
Pressure Relief Valve For High Flow Oxygen Therapy 40cmH20
Company
FLEXICARE MEDICAL LIMITED
Model
032-12-240U
Published
2020-01-28
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055788702115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055788702115050557887021155055788702115

GMDN Terms#

Term, Definition table
TermDefinition
Pressure relief valve, single-useA non-sterile device used to regulate the maximum pressure level in a circuit or system (typically containing gas) where it is essential not to exceed a pre-set maximum pressure. Should this pressure level be exceeded, this device will automatically open and vent the excess pressure from the circuit/system ensuring that an excessive pressure level is not sustained, thereby preventing damage to the patient or a parent device. It is typically used in anaesthesia machines and ventilators forming part of the breathing/gas delivery circuit/system, but may be applied to other functions. 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#

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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
00628101633448OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633455OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633462OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633530OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633547OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633554OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633585OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633592OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633608OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633615OhioOHIO MEDICAL, LLCBYX2026-10-15
00628101633400OhioOHIO MEDICAL, LLCBYX2026-10-12
00749756403375DeRoyalDEROYAL INDUSTRIES, INC.BYX2026-09-30
00628101633356OhioOHIO MEDICAL, LLCBYX2026-09-29
00628101633417OhioOHIO MEDICAL, LLCBYX2026-09-29
00848530087142Respiratory AccessorySunset Healthcare Solutions, Inc.BYX2025-11-19
00848530070236CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530070281CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00789091681564Oxygen TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681595CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681601CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00848530089375Suction KitSunset Healthcare Solutions, Inc.BYX2025-04-15
00848530094232AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094256AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094263AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094270AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094294AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094317AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094331AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094348AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530093891AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06