DEVICE: 8001 Series Foley Catheter Temperature Probe (H29780010634160)
Device Identifier (DI) Information
8001 Series Foley Catheter Temperature Probe
8001-063-416
In Commercial Distribution
8001-063-416
MEASUREMENT SPECIALTIES, INC.
8001-063-416
In Commercial Distribution
8001-063-416
MEASUREMENT SPECIALTIES, INC.
8001 Series Foley Catheter Temperature Probe, 16 FR
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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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: 16 French |
Device Record Status
a4cb6dbb-0d5e-43f2-a71f-3c8326beb5b6
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 |
---|---|---|---|---|---|
H29780010634161 | 10 | H29780010634160 | In Commercial Distribution | Inner Box | |
H29780010634162 | 10 | H29780010634161 | In Commercial Distribution | Outer Box |
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