FDA.reportPublic FDA data

BROSELOW™

Primary DI
10889483589359
Brand
BROSELOW™
Company
AIRLIFE
Model
7733YEL
Catalog number
7733YEL
Device description
BROSELOW™ REPLACEMENT POUCH (EMPTY)
Published
2025-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OKIEmergency Response Safety Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKIEmergency Response Safety KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483589353PackageGS11In Commercial Distribution
10889483589359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948358935330889483589353
1088948358935910889483589359

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, reusableA convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 ml0026200026202025-02-20
10889483617007AirLife™RC6Y023034RC6Y0230342025-02-27
10889483618264Air LifeAM-20002026-08-26
10889483618271Air LifeAM-21002026-08-26
10889483618288Air LifeAM-22002026-08-26
10889483618295Air LifeAM-30002026-08-26
10889483618301Air LifeAM-31002026-08-26
10889483618318Air LifeAM-32002026-08-26
10190752118379Vital Signs™2L39882L39882019-12-20
10190752118430Vital Signs™5030AE5030AE2020-02-20
10190752118973Vital Signs™5236AAE5236AAE2019-12-20
10190752119017Vital Signs™5372AE5372AE2019-12-20
10190752119215Vital Signs™A1UXOXXXA1UXOXXX2019-12-20
10190752119246Vital Signs™A1ZX1XXXA1ZX1XXX2020-02-20
10190752119369Vital Signs™A46517XXA46517XX2019-12-20
10190752119437Vital Signs™A46X8XXXA46X8XXX2019-12-20
10190752119628Vital Signs™A4FX1XXXA4FX1XXX2019-12-20
10190752119680Vital Signs™A4FX20X4VA4FX20X4V2020-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483588963BROSELOW™AIRLIFEOKI2025-03-13
10889483589144BROSELOW™AIRLIFEOKI2025-03-13
10889483589182BROSELOW™AIRLIFEOKI2025-03-13
10889483589267BROSELOW™AIRLIFEOKI2025-03-13
10889483589298BROSELOW™AIRLIFEOKI2025-03-13
10889483589304BROSELOW™AIRLIFEOKI2025-03-13
10889483589311BROSELOW™AIRLIFEOKI2025-03-13
10889483589328BROSELOW™AIRLIFEOKI2025-03-13
10889483589335BROSELOW™AIRLIFEOKI2025-03-13
10889483589342BROSELOW™AIRLIFEOKI2025-03-13
10889483589625BROSELOW™AIRLIFEOKI2025-03-13
10889483598276BROSELOW™AIRLIFEOKI2025-03-13
30889483588967BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589148BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589186BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589261BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589292BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589308BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589315BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589322BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589339BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589346BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589353BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483589629BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
30889483598270BROSELOW™Sunmed Group Holdings, LLCOKI2025-03-13
10889483588796BROSELOW™AIRLIFEOKI2025-03-07
10889483588819BROSELOW™AIRLIFEOKI2025-03-07
10889483588833BROSELOW™AIRLIFEOKI2025-03-07
10889483588857BROSELOW™AIRLIFEOKI2025-03-07
10889483588871BROSELOW™AIRLIFEOKI2025-03-07