FDA.reportPublic FDA data

MABIS

Primary DI
00767056156814
Brand
MABIS
Company
D-M-S HOLDINGS, INC.
Model
15-681-000
Catalog number
15-681-000
Device description
DIGITAL THERMOMETER W/BEEPER FEVER ALARM & MEMORY FAHRENHEIT
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OZKThermometer, Exhaled Breath

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZKThermometer, Exhaled BreathGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10767056156811PackageGS112Not in Commercial Distribution
30767056156815PackageGS112Not in Commercial Distribution
00767056156814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076705615681110767056156811
3076705615681530767056156815
00767056156814007670561568147670561568140767056156814

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.

Regulatory Flags#

DUNS number
062028220
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23
00767056600119MABIS05-260-01105-260-0112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063675130LPOWHangzhou Universal Electronic Co.,Ltd.OZK2024-05-28
00767056156395MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10767056156392MABISD-M-S HOLDINGS, INC.OZK2016-09-23
10767056156811MABISD-M-S HOLDINGS, INC.OZK2016-09-23
00036800396920TOPCARETopco Associates, LLCOZK2016-09-12
10036800396927TOPCARETopco Associates, LLCOZK2016-09-12
00681131060271RELIONWAL-MART STORES, INC.OZK2016-08-17
10681131060278RELIONWAL-MART STORES, INC.OZK2016-08-17