FDA.reportPublic FDA data

FOFO

Primary DI
06971066425639
Brand
FOFO
Company
Foshan Hongfeng Co., Ltd.
Model
BC68006
Published
2024-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971066425639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971066425639069710664256396971066425639

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
554404898
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971066426384FOFOBC680052024-06-06
06971066428340FOFOBC680022024-06-06
06971066429736FOFOBC64032024-06-06
06971066429439FOFOBC680012024-06-05
06971066420009FOFOHF6001+HF620122024-06-07
06971066422225FOFOHF6002+HF6012024-06-07
06971066422232FOFOHF6002U+HF-A2024-06-07
06971066422287FOFOHF6008+HF6092024-06-07
06971066422355FOFOHF6001+HF6P012024-06-07
06971066422881FOFOHF6005+HF6082024-06-07
06971066428081FOFOHF6001+HF6P01D2024-06-07
06971066428968FOFOHF6001+HF6052024-06-07
06971066420405FOFOHF603+HF60012024-06-06
06971066420634FOFOHF6002+HF6082024-06-06
06971066420894FOFOHF6002-17P+HF620122024-06-06
06971066420900FOFOHF601+HF60012024-06-06
06971066423246FOFOHF6002-17P+HF-A2024-06-06
06971066423741FOFOHF6002-17P+HF6012024-06-06
06971066424564FOFOHF6002+HF6012024-06-06
06971066424687FOFOHF6002+HF-A2024-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850022483387Dr. Noze Best NebulizerDr. Noze Best, LLCCCQ2026-05-26
00850079671010NavägeRhinosystems, Inc.CCQ2026-03-02
14026704714527LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2025-12-08
24026704714524LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2025-12-08
00850024829367Shusher CarePENO LLCCCQ2025-11-03
06945040113850CONTECContec Medical Systems Co., Ltd.CCQ2025-10-13
06945040110637CONTECContec Medical Systems Co., Ltd.CCQ2025-08-12
06973134772126silverfoxSilverfox Corporation LimitedCCQ2025-01-06
00840183528423BR Surgical, LLCBR Surgical, LLCCCQ2024-11-07
00628725098203VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedCCQ2024-08-20
50628725098208VixOne™ Nebulizer Kit Canadian Hospital Specialties LimitedCCQ2024-08-20
00851440007728Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00851440007735Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00851440007742Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007725Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007732Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
10851440007749Responsive RespiratoryRESPONSIVE RESPIRATORY, INC.CCQ2024-08-01
00810094577179CuraplexBOUND TREE MEDICAL, LLCCCQ2024-07-30
00840183522018BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183524128BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183525255BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
00840183526689BR Surgical, LLCBR Surgical, LLCCCQ2024-07-23
06971066426384FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066428340FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066429736FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
06971066429439FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-05
00628725096940Nebulizer KitCanadian Hospital Specialties LimitedCCQ2024-02-23
50628725096945Nebulizer KitCanadian Hospital Specialties LimitedCCQ2024-02-23
00840117326958Resp-O2 Empty Humidifier ( Jet ) Nebulizer, 500mLDynarex CorporationCCQ2023-12-28
00840117326965Empty Humidifier ( Jet ) NebulizerDYNAREX CORPORATIONCCQ2023-12-28