FDA.reportPublic FDA data

Caring Mill

Primary DI
00810025921033
Brand
Caring Mill
Company
Caring Mill
Model
BEUIH50
Catalog number
603.72
Device description
Nebulizer
Published
2020-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K121154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121154000ULTRASONIC NEBULIZERFoshan Gaunying Electronics Co., Ltd.2012-08-20CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810025921033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810025921033008100259210338100259210330810025921033

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic nebulizing systemAn assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
049283340
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810025921040Caring MillBEUIH58603.732020-11-02
00810025928858Caring Mill Saline Wound Wash928852025-07-03
00810025923020Caring MillEM44CM 642.762021-01-25
00810025921071Caring MillUA-767F-FSAUB-767F-FSA2021-10-21
00810025921170Caring MillDT-105-FSADT-105-FSA2021-10-21
00810025921774Caring MillBR60606.512020-12-07
00810025921088Caring MillUT-801-FSAUT-801-FSA2021-07-26
00810025922238caring millMT700-FSA2021-06-10
00810025922245caring millMT710-FSA 2021-06-10
00810025922252caring millBP3NM1-3WFSA2021-06-10
10810025922235caring millMT700-FSA2021-06-10
10810025922242caring millMT710-FSA 2021-06-10
10810025922259caring millBP3NM1-3WFSA2021-06-10
00810025922207caring millMT3001-FSA2021-06-09
00810025922214caring millMT19U1-FSA2021-06-09
00810025922221caring millIR1DY1-1 FSA2021-06-09
00810025922269caring millBP3NU1-3ZFSA2021-06-09
00810025922276caring millPF100-FSA2021-06-09
10810025922204caring millMT3001-FSA2021-06-09
10810025922211caring millMT19U1-FSA2021-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
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
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02