DEVICE: Mon-a-Therm (10884521828384)
Device Identifier (DI) Information
Mon-a-Therm
90044
In Commercial Distribution
Covidien LP
90044
In Commercial Distribution
Covidien LP
General Purpose Temperature Probe 400TM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35254 | General-purpose patient temperature probe, single-use |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FLL | Thermometer, electronic, clinical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K874514 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Atmospheric Pressure: between 12 and 106 KiloPascal |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between -13 and 131 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Catheter Gauge: 12 French |
Device Record Status
10cceb17-05e6-434c-a60c-f4abec0947d9
June 06, 2023
1
May 29, 2023
June 06, 2023
1
May 29, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884521828381 | 50 | 10884521828384 | In Commercial Distribution | PACK_OR_INNER_PACK | |
30884521828388 | 2 | 20884521828381 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com