FDA.reportPublic FDA data

Composite Respiratory Kit

Primary DI
00709078003615
Brand
Composite Respiratory Kit
Company
WESTMED, INC.
Model
0767
Device description
1 - Packaged 50' O2 Tubing (0052), 6 - Packaged Soft Cannula with 7' Tubing (0556), 1 - Barbed Connector (40076), 1 - Cylinder Wrench (20014), 1 - Key Chain (90027), 1 - No Smoking Sign (70816).
Published
2017-04-24
Public version status
Update
Distribution status
Not 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
CATCannula, Nasal, Oxygen
OGLOxygen Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1
CATCannula, Nasal, OxygenAnesthesiology1
OGLOxygen Administration KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078003612PackageGS110Not in Commercial Distribution
00709078003615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800361210709078003612
00709078003615007090780036157090780036150709078003615

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, basic"A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as ""nasal prongs"". This is a single-use device."

Regulatory Flags#

DUNS number
092673953
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078003028Composite Kit07932017-04-26
00709078003868Humidifier Adaptor04852017-05-26
00709078003899Composite Kit07942017-05-26
00709078005954OxyGo Bubble Humidifier1425-10142018-09-25
00709078007606Bubble Humidifier04802021-02-24
00709078014093Bubble Humidifier10022832022-03-31
00709078014277Bubble Humidifier010-1048582022-03-31
00709078014284Bubble Humidifier10022482022-03-31
00709078003011Composite Kit07922017-04-26
00709078003158Bubble Humidifier07952017-04-26
00709078003349Mod Kit Pulset™3362-912017-03-30
00709078003356Pulset3363-912017-03-30
00709078003974A-Line3100-302021-01-31
00709078004483Pulset3373-912017-08-31
00709078004612Pulset™ 1cc Syringe31002021-04-28
00709078005107Pulset™3165-912017-09-22
00709078006470Pulset3303-502022-05-31
00709078009082Pulset3173-142020-08-31
00709078011849A-Line3300-242020-09-30
00709078011863A-Line3100-202020-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530087142Respiratory AccessorySunset Healthcare Solutions, Inc.BYX2025-11-19
00848530070236CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530070281CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530083960Oxygen KitSunset Healthcare Solutions, Inc.OGL2025-05-19
00789091681564Oxygen TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681595CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681601CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681557Adulat Soft CannulaSunset Healthcare Solutions, Inc.CAT2025-04-24
00789091681571Adulat Soft CannulaSunset Healthcare Solutions, Inc.CAT2025-04-24
00848530089375Suction KitSunset Healthcare Solutions, Inc.BYX2025-04-15
00848530093891AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093907AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093914AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093921AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093938AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093945AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093952AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093969AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093976AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093983AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530093990AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094003AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094010AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094027AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094034AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094041AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094058AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094065AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094072AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06
00848530094089AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-06