FDA.report

Procure

Primary DI
30840330700352
Brand
Procure
Company
Twin Med, LLC
Model
1002249
Catalog number
1002249
Device description
Mask Aerosol Pediatric Elongated Vented W/O Tubing
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

Related Records

Contact Domains

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30840330700352PackageGS150In Commercial Distribution
10840330700358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3084033070035230840330700352
1084033070035810840330700358

GMDN Terms

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

Contacts

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 DIBrandModelCatalogPublished
30840330705869ProCurePCHCB002PCHCB0022025-11-26
30840330705876ProCurePCHCB002LPCHCB002L2025-11-26
30840330705883ProCurePCHCB004PCHCB0042025-11-26
30840330705890ProCurePCHWCS183PCHWCS1832025-11-26
30840330705906ProCurePCHWCS1415PCHWCS14152025-11-26
30840330705913ProCurePCHWCS144PCHWCS1442025-11-26
30840330705920ProCurePCHWCS124PCHWCS1242025-11-26
30840330705937ProCurePCHWCS143PCHWCS1432025-11-26
30840330701731ProCurePCKDK20PCKDK202025-05-31
30840330701748ProCurePCKDC20PCKDC202025-05-31
30840330701755ProCurePCCIT10PCCIT102025-05-31
30840330701762ProCurePCCIT30PCCIT302025-05-31
30840330701779ProCurePCUCIT14PCUCIT142025-05-31
30840330701786ProCurePCUCIT14RPCUCIT14R2025-05-31
30840330701793ProCurePCDB20HPCDB20H2025-05-31
30840330701809ProCurePCDB20PCDB202025-05-31
30840330701557ProCurePCHTF22PCHTF222025-04-17
30840330705425ProCure100897010089702025-01-20
30840330701816ProCurePC700PC7002024-11-21
30840330701823ProCurePC710PC7102024-11-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07045432120462Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120479Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120486Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120493Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
07045432120509Laerdal Silicone MasksLaerdal Medical ASBYG2026-01-29
20885632467407HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467414HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
20885632467469HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
07045432115987The BAG Mask size 1Laerdal Medical ASBYG2026-01-14
07045432115994The BAG Mask size 2 Laerdal Medical ASBYG2026-01-14
07045432116007The BAG Mask size 3 Laerdal Medical ASBYG2026-01-14
07045432116014The BAG Mask size 4Laerdal Medical ASBYG2026-01-14
07045432116021The BAG Mask size 5Laerdal Medical ASBYG2026-01-14
20889483221669Performance Home MedicalSUNMED, LLCBYG2025-12-31
20889483227265BiFLo™SUNMED, LLCBYG2025-12-30
20889483227272BiFLo™SUNMED, LLCBYG2025-12-30
20889483223977AirLife™SUNMED, LLCBYG2025-12-19
20889483224158AirLife™SUNMED, LLCBYG2025-12-19
20889483224295DeVilbissSUNMED, LLCBYG2025-12-19
20889483224684AirLife™SUNMED, LLCBYG2025-12-19
20889483224165AirLife™SUNMED, LLCBYG2025-12-18
20197344011114HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011749HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011756HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344011770HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
20197344042200HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
B0026300RescuerB.L.S. Systems LimitedBYG2025-11-24
B00263050RescuerB.L.S. Systems LimitedBYG2025-11-24
20197344011589HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
20197344011596HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14