FDA.reportPublic FDA data

Caring Mill

Primary DI
00810025921774
Brand
Caring Mill
Company
Caring Mill
Model
BR60
Catalog number
606.51
Device description
Insect Bite Healer
Published
2020-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810025921774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810025921774008100259217748100259217740810025921774

GMDN Terms#

Term, Definition table
TermDefinition
Insect bite/sting hyperthermia deviceA portable, battery-powered device intended to be used for the external treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the application of concentrated heat. The heat (around 50? Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It typically consists of a pocket-sized, hand-held housing containing electronics, batteries, and a skin-surface contact plate. It is available [non-prescription] over-the-counter (OTC) for home-use. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
049283340
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810025921040Caring MillBEUIH58603.732020-11-02
00810025928858Caring Mill Saline Wound Wash928852025-07-03
00810025923020Caring MillEM44CM 642.762021-01-25
00810025921071Caring MillUA-767F-FSAUB-767F-FSA2021-10-21
00810025921170Caring MillDT-105-FSADT-105-FSA2021-10-21
00810025921088Caring MillUT-801-FSAUT-801-FSA2021-07-26
00810025922238caring millMT700-FSA2021-06-10
00810025922245caring millMT710-FSA 2021-06-10
00810025922252caring millBP3NM1-3WFSA2021-06-10
10810025922235caring millMT700-FSA2021-06-10
10810025922242caring millMT710-FSA 2021-06-10
10810025922259caring millBP3NM1-3WFSA2021-06-10
00810025922207caring millMT3001-FSA2021-06-09
00810025922214caring millMT19U1-FSA2021-06-09
00810025922221caring millIR1DY1-1 FSA2021-06-09
00810025922269caring millBP3NU1-3ZFSA2021-06-09
00810025922276caring millPF100-FSA2021-06-09
10810025922204caring millMT3001-FSA2021-06-09
10810025922211caring millMT19U1-FSA2021-06-09
10810025922228caring millIR1DY1-1 FSA2021-06-09

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