FDA.reportPublic FDA data

Bestmed

Primary DI
20809148020055
Brand
Bestmed
Company
180 INNOVATIONS LLC
Model
DTT-1.BM
Device description
A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature from the temperal artery. The device has a rigid tip and an LCD display. It is designed to take a temperature reading in approximately 5 seconds. This is a reusable device.
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809148020055PackageGS13In Commercial Distribution
40809148020059PackageGS14In Commercial Distribution
00809148020051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2080914802005520809148020055
4080914802005940809148020059
00809148020051008091480200518091480200510809148020051

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
+1(303)271-0300info@180innovations.com

Regulatory Flags#

DUNS number
126646582
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00809148200750BestmedHTD8813C2020-04-28
00809148200804PolygreenKI-82802020-04-28
40809148200758BestmedHTD8813C2020-04-28
20809148200808PolygreenKI-82802020-04-28
00809148082714N/AKI-82712019-04-24
00809148243450Rite AidKD-2250.RA2018-03-07
00809148253329Rite AidKI-8271.RA2018-11-08
00809148317397Rite AidKD-235.RA2016-10-20
00809148322360Rite AidKI-8170L.RA2016-10-20
00809148323459Rite AidKD-2201L.RA2016-10-20
00809148428512Rite AidKD-2050.RA2016-10-20
00809148504322Rite AidKD-113.RA2016-10-20
00809148510699Rite AidKD-2050baby.RA2016-10-20
00809148528519Rite AidKD-1780FF.RA2018-10-25
00809148576138Rite AidKD-133baby.RA2016-10-20
00809148601694Rite AidKD-1780FFB.RA2018-10-25
00809148604237Rite Aid740.RA2016-10-20
00809148604329RITE AIDKD-1780-1.RA2018-03-17
00809148676135Rite AidKD-1780Baby.RA2018-03-17
00809148686066Rite AidKD-2280.RA2017-11-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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