FDA.reportPublic FDA data

OXYGEN MASK INFANT,W/7FT TUBE(UNIVERSAL CONNECTOR ON ONE SIDE)

Primary DI
04716770811338
Brand
OXYGEN MASK INFANT,W/7FT TUBE(UNIVERSAL CONNECTOR ON ONE SIDE)
Company
BESMED HEALTH BUSINESS CORP.
Model
OM-81133
Device description
OXYGEN MASK INFANT,W/7FT TUBE(UNIVERSAL CONNECTOR ON ONE SIDE)
Published
2017-11-03
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
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04716770811338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04716770811338047167708113384716770811338

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen therapy systemAn assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658023775
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04716770703022HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
04716770703039HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
04716770703060HMEF (Dead space 60ml)FL-703062026-02-11
04716770701127HME W/Luer lock port (Dead space 45ml)FL-701122026-02-11
04716770701158Angled HME with luer lock portFL-701152026-02-11
04716770702230Bacterial Filter (Dead space 32ml)FL-702232026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
14716770703067HMEF (Dead space 60ml)FL-703062026-02-11
04716770341460Besmed Menstrual CupPE-341462022-12-08
04716770341477Besmed Menstrual CupPE-341472022-12-08
04716770341484Besmed Menstrual CupPE-341482022-12-09
04716770341491Besmed Menstrual CupPE-341492022-12-09
04716770931005INCENTIVE SPIROMETER,600/900/1200MLTB-931002016-09-06
04716770932507INCENTIVE SPIROMETER,2500MLTB-932502016-09-06
04716770932514 INCENTIVE SPIROMETERTB-932512017-12-15
04716770935003 INCENTIVE SPIROMETER,5000MLTB-935002016-09-06
04716770935010 INCENTIVE SPIROMETERTB-935012017-12-15
04716770790015Elbow connetor 18MM ID for nebulizerMP-790012017-12-13
04716770791043MOUTH PIECE (OD:18mm,22mm)MP-791042017-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919008Salter Labs® Adult Comfort Face TentSALTER LABSBYG2026-06-09
00607411919053Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
00607411919060Salter Labs® Oxygen MaskSALTER LABSBYG2026-06-09
04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3ASSOMEDIKA, OOOBYG2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14