FDA.reportPublic FDA data

Procure

Primary DI
10840330700501
Brand
Procure
Company
Twin Med, LLC
Model
1002254
Catalog number
1002254
Device description
Small Volume Nebulizer Adult (MVP) Aerosol Mask 7' Kink Resistant Tubing Standard
Published
2022-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
30840330700505PackageGS150In Commercial Distribution
10840330700501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070050530840330700505
1084033070050110840330700501

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It 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. It is designed to be placed on a benchtop/flat surface during use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
804-776-2873xx@xx.xx

Regulatory Flags#

DUNS number
107071289
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840330701911ProCurePC400PC4002026-05-27
10840330701928ProCurePC405PC4052026-05-27
10840330701935ProCurePC410PC4102026-05-27
10840330701942ProCurePC420PC4202026-05-27
10840330701959ProCurePC430PC4302026-05-27
10840330701966ProCurePC500PC5002026-05-27
10840330701973ProCurePC510PC5102026-05-27
10840330701980ProCurePC520PC5202026-05-27
10840330701997ProCurePC530PC5302026-05-27
10840330702253ProCurePCM500PCM5002026-05-27
10840330702260ProCurePCM510PCM5102026-05-27
10840330702277ProCurePCM520PCM5202026-05-27
10840330702284ProCurePCM530PCM5302026-05-27
10840330704868ProCurePCSS520PCSS5202026-05-27
10840330704875ProCurePCSS525PCSS5252026-05-27
10840330705162ProCurePC550PC5502026-05-27
10840330705179ProCurePC560PC5602026-05-27
10840330705186ProCurePC570PC5702026-05-27
10840330705193ProCurePC580PC5802026-05-27
10840330705209ProCurePC450PC4502026-05-27

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