FDA.reportPublic FDA data

Unimed

Primary DI
06945664828772
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
TMQ-CA-14FR
Device description
Disposable temperature sensor /400 series/Adult/catheter/FC-14FR
Published
2021-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945664828772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945664828772069456648287726945664828772

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527971025
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
true
Expiration date on label
true
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
06936735488353UnimedD6-RT180D-I2025-09-26
06936735497195Unimed D33-16161-I2025-09-26
06936735496501UnimedD33-13161-I2025-03-28
06936735494200Unimed24155P2025-03-13
06936735494675Unimed24155P-I2025-03-13
06936735495214UnimedE10R/30-KAR-P2025-03-13
06936735496099UnimedE10R/30-KAR-P/I2025-03-13
06936735496570UnimedAD-KAR-2101482025-03-13
06936735450503UnimedU410B-372022-04-11
06936735450510Unimed U410E-1212022-04-11
06936735450527UnimedU110-65D2022-04-11
06936735450534UnimedPU410S-01P2022-04-11
06936735450541UnimedU410-2242022-04-11
06936735451463UnimedU4M10-08L(NPS)2022-05-27
06936735451470UnimedT533-49R2022-05-27
06936735451487UnimedU310-195P2022-05-27
06936735451500UnimedU103S-2542022-05-27
06936735454105Unimed GS DP-11/A2022-11-01
06936735454518Unimed PU110-46D2022-12-08
06936735454525Unimed PU903-2032022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationDSA2026-05-26
00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationDSA2026-05-26
07613365003925SCHILLERSchiller AGDSA2026-05-26
07613365003932SCHILLERSchiller AGDSA2026-05-26
07613365003949SCHILLERSchiller AGDSA2026-05-26
07613365003956SCHILLERSchiller AGDSA2026-05-26
07613365004199SCHILLERSchiller AGDSA2026-05-26
07613365004205SCHILLERSchiller AGDSA2026-05-26
07613365004212SCHILLERSchiller AGDSA2026-05-26
07613365004229SCHILLERSchiller AGDSA2026-05-26
10653405063797CONMEDConmed CorporationDSA2026-03-24
20653405017766CONMEDConmed CorporationDSA2026-03-24
20653405019777CONMEDConmed CorporationDSA2026-03-24
20653405022821CONMEDConmed CorporationDSA2026-03-24
20653405022838CONMEDConmed CorporationDSA2026-03-24
20653405022951CONMEDConmed CorporationDSA2026-03-24
20653405023057CONMEDConmed CorporationDSA2026-03-24
20653405023071CONMEDConmed CorporationDSA2026-03-24
20653405023163CONMEDConmed CorporationDSA2026-03-24
20653405023170CONMEDConmed CorporationDSA2026-03-24
20653405023385CONMEDConmed CorporationDSA2026-03-24
20653405023545CONMEDConmed CorporationDSA2026-03-24
20653405034701CONMEDConmed CorporationDSA2026-03-24
20653405036194CONMEDConmed CorporationDSA2026-03-24
20653405059858CONMEDConmed CorporationDSA2026-03-24
G662ME590132J1MaguireMaguire Enterprises, Inc.DSA2026-03-20
00884838117433NOUNPhilips Medizin Systeme Böblingen GmbHDSA2026-03-19
00840416606676FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-03-16
00840416606683FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-03-16
00840416606690FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-03-16