FDA.reportPublic FDA data

MDHC

Primary DI
06974669350360
Brand
MDHC
Company
MDHC Life Technologies (Kunshan) Co., LTD.
Model
1 set/bag
Device description
Disposable Intransal Atomization Device
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
06974669350360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974669350360069746693503606974669350360

GMDN Terms#

Term, Definition table
TermDefinition
Atomizer, ventilatoryA non-powered device intended to accept a medication canister and to be integrated within a mechanical or manual ventilation assembly (e.g., ventilator breathing circuit/endotracheal tube, pulmonary resuscitator) to provide liquid medication in aerosolized form for the patient to breathe during ventilation. It typically includes a medicine chamber spacer; unlike a nebulizer it lacks a baffle. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
625685749
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974669350292MDHC20 pcs/bag2023-07-06
06974669350193MDHC5 pcs2023-07-06
06974669350209MDHC1 pair2023-07-06
06974669350216MDHC1 pcs2023-07-06
06974669350223MDHC10 pcs2023-07-06
06974669350230MDHC1 pcs/box2023-07-06
06974669350247MDHC5 units/case2023-07-06
06974669350254MDHC250 tips/box2023-07-06
06974669350261MDHC5 pcs/bag2023-07-06
06974669350278MDHC10 pcs/box2023-07-06
06974669350285MDHC5 pcs/bag2023-07-06
06974669350308MDHC1 pcs/bag2023-07-06
06974669350315MDHC6 pcs/box2023-07-06
06974669350322MDHC5 pcs/bag2023-07-06
06974669350339MDHC12 pcs/Case2023-07-06
06974669350346MDHC50 serving/box2023-07-06
06974669350353MDHC1 set/bag2023-07-06
06974669350377MDHC5 pcs/bag2023-07-06
06974669350384MDHC5 pcs/bag2023-07-06

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
06971066425639FOFOFoshan Hongfeng Co., Ltd.CCQ2024-06-06
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