FDA.reportPublic FDA data

ironwear

Primary DI
10607659787206
Brand
ironwear
Company
IRONWEAR
Model
7872-B
Device description
Digital Thermometer
Published
2020-10-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10607659787206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060765978720610607659787206

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
8003292235MARVIN@IRONWEAR.COM

Regulatory Flags#

DUNS number
060015430
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607659524019ironwear5240-B, MD2020-12-07
00607659524026ironwear5240-B, LG2020-12-07
00607659524033ironwear5240-B, XL2020-12-07
00607659524040ironwear5240-B, 2XL2020-12-07
00607659524118ironwear5241-B, SM2020-12-07
00607659524125ironwear5241-B, MD2020-12-07
00607659524132ironwear5241-B, LG2020-12-07
00607659524149ironwear5241-B, XL2020-12-07
00607659524156ironwear5241-B, 2XL2020-12-07
00607659524200ironwear5242-B, SM2020-12-07
00607659524217ironwear5242-B, MD2020-12-07
00607659524224ironwear5242-B, LG2020-12-07
00607659524231ironwear5242-B, XL2020-12-07
00607659524248ironwear5242-B, 2XL2020-12-07
10607659150314ironwear1503-B2020-10-21
10607659150413ironwear1504-B2020-10-21

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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
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22