FDA.reportPublic FDA data

WITCAREMED

Primary DI
06976824740184
Brand
WITCAREMED
Company
Shenzhen Witcaremed Medical Technology Co., Ltd
Model
NBM-3B
Device description
Portable (Ultrasonic) Nebulizer
Published
2024-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K230379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230379000Portable (Ultrasonic) NebulizerDongguan Simzo Electronic Technology Co., Ltd.2023-11-27CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976824740184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976824740184069768247401846976824740184

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory nebulizer, non-heatedAn electrically-powered, hand-held, portable device intended to be used in the home to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may employ various technologies (ultrasonic, vibrating mesh, or compressor jet type) and consists of a pocket-size unit containing a reservoir to be filled with medication/fluids, and a retractable mouthpiece or attached mask. This device is not a nebulizing chamber.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
699351819
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976824740054WITCAREMEDBC-CA380 (white)2024-02-17
06976824740030WITCAREMEDBC-CA380 (black)2024-02-17
16976824740051WITCAREMEDBC-CA380 (white)2024-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
00848530087524Power and AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087531Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099893Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099923Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087517Nebulizer Medicine CupSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099107Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087500Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093884Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095062Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095079Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530089818Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093853Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530094805Nebulizer KitSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530098216Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100377Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100384Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30