FDA.reportPublic FDA data

First Responder Kit

Primary DI
B859FRK10109
Brand
First Responder Kit
Company
CBX LLC
Model
FRK101
Catalog number
FRK101
Device description
First Responder Kit contains CPR Mask with oxygen port, one pair of nitrile gloves, emergency shears, safety prep razor, dry cleaning towel and NaCl wet wipe.
Published
2020-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B859FRK10109PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
First aid kit, non-medicated, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
110960383
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810104540896Cubix SafetyFRK-NLXFRK-NLX012025-04-18
B859ERM1010Emergency Rescue MaskERM1012020-02-15
B859FRK1021First Responder KitFRK102FRK1022021-04-01

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