FDA.reportPublic FDA data

JET NEBULIZER MASK ,ADULT SET 7Ft OXYGEN TUBING

Primary DI
04716770315119
Brand
JET NEBULIZER MASK ,ADULT SET 7Ft OXYGEN TUBING
Company
BESMED HEALTH BUSINESS CORP.
Model
NB-31511
Device description
JET NEBULIZER MASK ,ADULT SET 7Ft OXYGEN TUBING
Published
2017-12-14
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
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091272000BESMED JET NEBULIZER BOTTLE SETBesmed Health Business Corp2009-11-10CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04716770315119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04716770315119047167703151194716770315119

GMDN Terms#

Term, Definition table
TermDefinition
AtomizerA non-ventilatory device that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658023775
Device count
1
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

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Primary DI, Brand, Company table
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10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
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10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
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