DEVICE: MEAS 4400 Series Temperature Probe (H29744680)
Device Identifier (DI) Information
MEAS 4400 Series Temperature Probe
4468
In Commercial Distribution
861557
MEASUREMENT SPECIALTIES, INC.
4468
In Commercial Distribution
861557
MEASUREMENT SPECIALTIES, INC.
Foley Catheter Temperature Probe, 18 FR
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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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 |
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EZL | Catheter, Retention Type, Balloon |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -5 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 18 French |
Device Record Status
230348ce-599a-44a2-b643-6a26269bd477
March 29, 2018
2
July 01, 2016
March 29, 2018
2
July 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
H29744682 | 10 | H29744681 | In Commercial Distribution | Carton | |
H29744681 | 10 | H29744680 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
800-899-9783
medfeedback@te.com
medfeedback@te.com