FDA.reportPublic FDA data

Mon-a-Therm

Primary DI
30884521031573
Brand
Mon-a-Therm
Company
Covidien LP
Model
90045
Device description
Skin Temperature Probe 400TM
Published
2016-09-24
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
K875234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875234000MON-A-THERM'S SKIN TEMPERATURE SENSORMon-A-Therm, Inc.1988-01-19FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521031579PackageGS12In Commercial Distribution
20884521031576PackageGS150In Commercial Distribution
30884521031573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452103157910884521031579
2088452103157620884521031576
3088452103157330884521031573

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to UV

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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10884521853850Shiley1108802026-10-25
10884521853867Shiley1108852026-10-25
10884521853874Shiley1108902026-10-25
10884521856547Touch SurgeryMDS300282026-10-23
10884521861114Vital SyncVITALSYNCSW032026-10-25
10884521039902Surgipro llVPF-703-MX2015-09-02
10884521063433Ti-CronX-11362015-09-02
10884521073951Versaport PlusNB8STF2016-09-24
10884521195677Surgipro IIVP-653-MX2015-09-02
10884521546349Surgipro IIVP86X2016-09-24
10884521701991MonosofCN793G2017-10-10
10884521702073Surgipro IIVP746XG2017-10-10
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