FDA.reportPublic FDA data

ABN Digital Thermometer

Primary DI
08997021263472
Brand
ABN Digital Thermometer
Company
SUGIH INSTRUMENDO ABADI, PT
Model
DT-900-101
Device description
ABN Digital Thermometer is a medical used for measuring human body temperature.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08997021263472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08997021263472089970212634728997021263472

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

Regulatory Flags#

DUNS number
726548899
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08997021260105ABN Precision Aneroid Sphygmomanometer, Adult, Black AS-0212025-07-25
08997021260112ABN Precision Aneroid Sphygmomanometer, Infant, BlackAS-0232025-07-25
08997021260129ABN Precision Aneroid Sphygmomanometer, Child, BlackAS-0252025-07-25
08997021260136ABN Precision Aneroid Sphygmomanometer, Large Adult, BlackAS-0262025-07-25
08997021260143ABN Precision Aneroid Sphygmomanometer, Thigh, BlackAS-0272025-07-25
08997021260754ABN Classic Stethoscope, Adult, BlackSS-021-BK2023-06-09
08997021260006ABN PREMIUM Aneroid Sphygmomanometer, Adult, BlackAS-0112023-06-09
08997021263526ABN Deluxe PenlightPL-900-2122023-06-09
08997021263762Direct Supply - Attendant Handheld Aneroid SphygmomanometerDSA-HS2016-12-13
08997021263779Direct Supply - Attendant Mobile Clock Aneroid SphygmomanometerDSA-MS2016-12-13

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22