FDA.reportPublic FDA data

BROSELOW™

Primary DI
10889483588796
Brand
BROSELOW™
Company
AIRLIFE
Model
7700BAW
Catalog number
7700BAW
Device description
BROSELOW™ OXYGEN DELIVERY MODULES
Published
2025-03-07
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
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
30889483588790PackageGS140In Commercial Distribution
10889483588796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948358879030889483588790
1088948358879610889483588796

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation kit, single-useA collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration 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
10889483589359BROSELOW™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
10889483588819BROSELOW™AIRLIFEOKI2025-03-07
10889483588833BROSELOW™AIRLIFEOKI2025-03-07
10889483588857BROSELOW™AIRLIFEOKI2025-03-07
10889483588871BROSELOW™AIRLIFEOKI2025-03-07