DEVICE: Mon-a-Therm (10884521826434)

Device Identifier (DI) Information

Mon-a-Therm
90054
In Commercial Distribution

Covidien LP
10884521826434
GS1

1
058614483 *Terms of Use
Foley with Temperature Sensor 400TM
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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?
34917 Indwelling urethral drainage balloon catheter, non-antimicrobial
A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KOD CATHETER, UROLOGICAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K831567 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 10 French
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Device Record Status

06bf55bd-caaa-44da-b7d5-512b1898d3ac
June 13, 2025
2
May 29, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30884521826438 2 20884521826431 In Commercial Distribution CASE
20884521826431 10 10884521826434 In Commercial Distribution PACK_OR_INNER_PACK
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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