FDA.reportPublic FDA data

Composite Respiratory Kit: A&R Medical

Primary DI
00709078003264
Brand
Composite Respiratory Kit: A&R Medical
Company
WESTMED, INC.
Model
0758
Device description
Composite Respiratory Kit: A&R Medical(2) 0050, (4) 0556, (2) Barbed Oxygen Connector, (1) Nipple and Nut, (1) Oxygen (No Smoking) Sign
Published
2017-03-28
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
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
10709078003261PackageGS110In Commercial Distribution
00709078003264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800326110709078003261
00709078003264007090780032647090780032640709078003264

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
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
00709078011900A-Line3300-262020-09-30
00709078012013Pulset36002020-09-30
00709078012037Pulset3600-202020-09-30
00709078013287Atellica® VTR Syringes115613402022-02-28
00709078013300Atellica® VTR Syringes115613412022-02-28
00709078013324Atellica® VTR Syringes115613422022-02-28
00709078013348Atellica® VTR Syringes115613432022-02-28
00709078013362Atellica® VTR Syringes115613442022-02-28
00709078013386Atellica® VTR Syringes115613452022-02-28
00709078013409Atellica® VTR Syringes115613462022-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178885602ViveVIVE HEALTH LLCBYX2026-08-03
00818323027358ViveVIVE HEALTH LLCBYX2026-08-03
00851440007575Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BYX2026-07-22
04719874951023Create BiotechCREATE BIOTECH CO., LTD.CAT2026-07-21
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