FDA.reportPublic FDA data

Mon-a-Therm

Primary DI
10884521828391
Brand
Mon-a-Therm
Company
Covidien LP
Model
90050
Device description
General Purpose Temperature Probe 400TM
Published
2023-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, electronic, clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240077000
K874514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240077000Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)Covidien2024-08-20FLL
K874514000HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEMallinckrodt Critical Care1988-01-29FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521828398PackageGS150In Commercial Distribution
30884521828395PackageGS12In Commercial Distribution
10884521828391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452182839820884521828398
3088452182839530884521828395
1088452182839110884521828391

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge9French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure12 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
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