FDA.reportPublic FDA data

LEADER

Primary DI
00096295128796
Brand
LEADER
Company
Cardinal Health 110, Inc.
Model
5238548
Catalog number
5238548
Device description
LDR Pediatric Nebulizer System Pete the Dog
Published
2017-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K043238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043238000COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIESEmg Technology Co., Ltd.2005-07-06CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50096295128791PackageGS16In Commercial Distribution
00096295128796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5009629512879150096295128791
00096295128796000962951287960962951287960096295128796

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity13 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)200-6313xxx@xxx.xxx

Regulatory Flags#

DUNS number
063997360
Device count
1
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00096295134155LEADER542780254278022019-05-01
00096295133219LEADER540277154027712020-01-02
00096295141504LEADER574184857418482022-01-14
00096295141511LEADER574185557418552022-01-14
00096295141528LEADER574186357418632022-01-14
00096295141535LEADER574187157418712022-01-14
00096295141542LEADER574188957418892022-01-14
00096295137309LEADER551288455128842019-06-20
00096295120851LEADER449066044906602019-10-21
00096295137347LEADER551320555132052019-10-21
00096295141146LEADER574643357464332022-01-06
00096295128789LEADER523850652385062017-02-23
00096295129212LEADER527880952788092017-02-23
00096295133202LEADER540276354027632019-07-26
00096295145137LEADER596875559687552025-09-09
50096295145132LEADER596875559687552025-09-09
00096295137262LEADER551284355128432019-06-20
00096295137293LEADER551287655128762019-08-29
00096295137279LEADER551285055128502019-06-20
00096295120905LEADER449081944908192017-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
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
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
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10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02