FDA.reportPublic FDA data

Geratherm Baby ColorChoice Blue Digital Thermometer

Primary DI
00614801300612
Brand
Geratherm Baby ColorChoice Blue Digital Thermometer
Company
R.G. ENTERPRISES (U.S.A.), INC.
Model
RETAIL Blue Digital Thermometer w- backlight
Catalog number
30061
Device description
Digital thermometer with backlight, 10 second readings, beeps when ready, flextip, jumbo display, waterproof, auto shut-off, dual scale provided with protective case.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K070028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070028000CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETERActherm, Inc.2007-02-08FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614801300612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614801300612006148013006126148013006120614801300612

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

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
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

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