FDA.reportPublic FDA data

DataTherm II

Primary DI
16148015015013
Brand
DataTherm II
Company
R.G. ENTERPRISES (U.S.A.), INC.
Model
Datatherm II
Catalog number
501501
Device description
Lightweight portable continuous temperature monitor used to measure human body temperature and stores temperature readings at preset time intervals. Features on/off, mode access and scrolling feature buttons, special Lock feature for safety, belt clip on back of monitor, features both High and Low adjustable alarm settings, uses 2, 1.5 volt AA batteries, disposable 1M or 2M temperature probes, dimensions (3.16 x 2.37 x .71).
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070878000DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300Rg Medical Diagnostics2007-06-05FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16148015015013PackageGS11In Commercial Distribution
00614801150118PrimaryGS10
06148015015016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1614801501501316148015015013
00614801150118006148011501186148011501180614801150118
06148015015016061480150150166148015015016

GMDN Terms#

Term, Definition table
TermDefinition
Continuous electronic patient thermometer, battery-poweredA battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-14 Degrees Fahrenheit140 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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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