FDA.reportPublic FDA data

Medical Warming Systems

Primary DI
00614801000017
Brand
Medical Warming Systems
Company
R.G. ENTERPRISES (U.S.A.), INC.
Model
Power Supply Unit
Catalog number
82009
Device description
Power Supply Unit for 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.
Published
2025-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00614801000017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614801000017006148010000176148010000170614801000017

GMDN Terms#

Term, Definition table
TermDefinition
Basic power supply, reusableA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-22 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
928998905
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614801001304Geratherm Medical Warming SystemsMini-Rescue II UniqueResc R130806122016-09-01
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
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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