FDA.reportPublic FDA data

Procure

Primary DI
30840330700369
Brand
Procure
Company
Twin Med, LLC
Model
1002231
Catalog number
1002231
Device description
Mask Venturi Adult W/complete set: diluter jets and humidity cup
Published
2022-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330700369PackageGS150In Commercial Distribution
10840330700365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070036930840330700369
1084033070036510840330700365

GMDN Terms#

Term, Definition table
TermDefinition
Aerosol face mask, rebreathing, single-useA flexible, form-shaped device that is placed over the nose and mouth to deliver aerosolized particles/gases to a patient's airway. It is typically used in conjunction with a nebulizer or medicine chamber spacer for the delivery of medication in either a healthcare or home setting. It is made of high-grade resins or other materials to produce a soft, flexible mask that will create an airtight seal against the patient's face. It may include a headstrap and is available in a range of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-819-1635sanderson@twinmed.com

Regulatory Flags#

DUNS number
107071289
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840330705599ProCurePCSDPN500PCSDPN5002026-05-12
10840330706695ProCurePCHF3005PCHF30052026-05-07
10840330706701ProCurePCHF3006PCHF30062026-05-07
10840330702574ProCurePCGBMB60PPCGBMB60P2026-05-06
10840330702581ProCurePCGBMB60WPCGBMB60W2026-05-06
10840330702598ProCurePCGBMB72PPCGBMB72P2026-05-06
10840330702604ProCurePCGBPB72PPCGBPB72P2026-05-06
10840330704882ProCurePCFS200PCFS2002026-05-06
10840330702291ProCurePC136PC1362026-05-05
10840330702307ProCurePC137PC1372026-05-05
10840330702314ProCurePC138PC1382026-05-05
10840330704363ProCurePC167PC1672026-05-05
10840330706558ProCurePCDT60PCDT602026-05-05
10840330706565ProCurePCIT01PCIT012026-05-05
10840330706596ProCurePC631PC6312026-05-05
10840330706671ProCurePC601PC6012026-05-05
10840330705858ProCurePCHC10044PCHC100442026-05-04
10840330706688ProCurePCHSWG15PCHSWG152026-05-04
10840330701560ProCurePCHTF45PCHTF452026-04-28
10840330701577ProCurePCHTF611PCHTF6112026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
08697645018112ENDURE INDUSTRIESENDURE INDUSTRIESBYG2025-10-16
14026704648150HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03
14026704648235HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03