FDA.reportPublic FDA data

Geratherm Medical Warming Systems

Primary DI
00614801001304
Brand
Geratherm Medical Warming Systems
Company
R.G. ENTERPRISES (U.S.A.), INC.
Model
Mini-Rescue II UniqueResc R130
Catalog number
80612
Device description
Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached. Operates using battery or medical grade power supply.
Published
2016-09-01
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
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093694000GERATHERM UNIQUERESCGeratherm Medical AG2010-09-20DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614801001304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614801001304006148010013046148010013040614801001304

GMDN Terms#

Term, Definition table
TermDefinition
Rescue blanketA large piece of fabric material specially designed to keep a person warm and to prevent the further loss of body heat in an emergency rescue situation. It is typically used by emergency medical services (EMS) and typically includes a heat-reflecting metal surface [e.g., aluminium (Al)] to help retain body heat. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height19Inch
Length33Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-22 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248-504-6726MaryRN@rgmd.com

Regulatory Flags#

DUNS number
928998905
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614801001502Geratherm Medical Warming SystemsSuper Mini-Rescue II Unique Resc+ R-150806132016-08-31
00614801000062Medical Warming SystemsBattery to Blanket Adaptor Cable820132025-07-09
00614801000079Medical Warming SystemsAC/DC Adaptor Cable820142025-07-09
00614801000086Medical Warming SystemsCigarette Lighter Adaptor Cable820162025-07-09
00614801000000Medical Warming SystemsCharger Assembly Lithium Ion Battery820252025-04-03
00614801000017Medical Warming SystemsPower Supply Unit820092025-04-03
00614801000024Medical Warming SystemsBattery Adapter Cable820242025-04-03
00614801000031Medical Warming SystemsAux Vehicle Cable820192025-04-03
00614801000048Medical Warming SystemsUltralife Battery Assembly820392025-04-03
00614801000055Medical Warming SystemsBrentronics Battery Assembly820152025-04-03
00614801150118DataTherm IIDatatherm II5015012016-09-01
16148015015013DataTherm IIDatatherm II5015012016-09-01
00614801200103GERATHERM MERCURY FREE GLASS THERMOMETERORAL THERMOMETER200102016-09-01
00614801200417GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER GLASS ORAL THERMOMETER IN MAGNIFYING CASE200412016-09-01
00614801200516GERATHERM MERCURY FREE GLASS THERMOMETERRECTAL THERMOMETER200512016-09-01
00614801200615GerathermClinical Basal Thermometer200612016-09-01
00614801400701GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER GLASS HYPOTHYROID BASAL THERMOMETER WITH BLUE COL400702016-09-01
20614801200107GERATHERM MERCURY FREE GLASS THERMOMETERORAL THERMOMETER200102016-09-01
00614801200301GERATHERM MERCURY FREE GLASS ORAL THERMOMETERRETAIL GLASS ORAL THERMOMETER200302016-09-01
00614801200400GERATHERM MAGNATHERM MERCURY FREE GLASS THERMOMETERRETAIL GLASS ORAL THERMOMETER IN MAGNIFYING CASE200402016-09-01

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Primary DI, Brand, Company table
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