FDA.reportPublic FDA data

SootheNeb

Primary DI
00816042014758
Brand
SootheNeb
Company
FORA CARE INC.
Model
NBL300b
Device description
Compressor Nebulizer
Published
2023-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816042014758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816042014758008160420147588160420147580816042014758

GMDN Terms#

Term, Definition table
TermDefinition
Benchtop nebulizer, non-heatedAn assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004340807
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
00816042016080FORATest N'GO Advance2026-06-24
00816042013638FORA30G2026-06-23
00816042014543FORATest N'GO Advance Voice2025-05-06
00816042015045FORASpiro10b2026-05-18
00816042015052FORASpiro10b2026-05-18
00816042016417FORAGTel/Test N'GO Advance/Test N’GO Advance Voice/Tes2026-03-20
00816042016387FORATest N'GO Advance/Test N'GO Advance Voice2026-04-27
00816042013577FORAGTel/Test N'GO Advance/Test N'GO Advance Voice/Goj2020-12-22
00816042013669FORATest N'GO Advance Pro 2020-05-05
00816042013881ForaCareGD202020-04-06
00816042013911FORAG202023-07-03
00816042015038FORAGTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
00816042013850FORA 6 Connect2020-02-17
00816042010200FORAV10/D10/D202016-12-20
00816042010675FORAV30/G30/Premium V102016-11-15
00816042010828ForaCareGD202017-04-03
00816042010859Pet GlucoPet Gluco2018-08-07
00816042011221FORAGD502017-04-04
00816042011610FORAG20/D302017-05-09
00816042011634FORAMD2017-06-13

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
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
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
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10888277657625MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01