FDA.reportPublic FDA data

Unimed

Primary DI
06945664858663
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
TOP-WA-002L
Device description
Smart Temp. Probe/Welch Allyn/Oral/Blue/2.5M/With sheath
Published
2020-11-11
Public version status
Update
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
06945664858663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945664858663069456648586636945664858663

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, reusableA temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527971025
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945664833790UnimedHPMA5-90DS2016-08-22
06945664833837UnimedMQM5-90DS2016-08-22
06945664833875UnimedLQ5-90DP02016-08-22
06945664833905UnimedHTM5-90DS2016-08-22
06945664833974UnimedMQM3-90DS2016-08-22
06945664834063UnimedLQ5-90DS02016-08-22
06945664834186UnimedATM5-90DS2016-08-22
06945664834193UnimedD3M-90DS2016-08-22
06945664834209UnimedHPM3-90DS2016-08-22
06945664834254UnimedLDT3-90DP02016-08-22
06945664834414UnimedLHT5-90DP02016-08-22
06945664834452UnimedHP5-90DPM2016-08-22
06945664834469UnimedLPA5-90DS02016-08-22
06945664834537UnimedLPA5-90DP02016-08-22
06945664834735UnimedL5-90DP02016-08-22
06945664835046UnimedMQM5-90DP2016-08-22
06945664835077UnimedLKB6-90DP02016-08-22
06945664835084UnimedL3-90DP02016-08-22
06945664835640UnimedLHT5-90DS02016-08-22
06945664835671UnimedHPA5-90DP2016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08698870325297FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325310FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325389FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870335265FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870357830FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870368867FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870368874FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870371577FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870372604FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870376251FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870377968FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
10192253068986CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253068993CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069006CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069013CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069020CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069037CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069044CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069051CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069068CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069075CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069082CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069099CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
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10834098000904Disposable CapsEXERGEN CORPORATIONFLL2023-06-13
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10884521828391Mon-a-ThermCovidien LPFLL2023-05-29