DEVICE: Fisher & Paykel Healthcare (09420012433145)
Device Identifier (DI) Information
Fisher & Paykel Healthcare
NC020-20
In Commercial Distribution
NC020-20
FISHER & PAYKEL HEALTHCARE LIMITED
NC020-20
In Commercial Distribution
NC020-20
FISHER & PAYKEL HEALTHCARE LIMITED
SureSense™- Single Use Temperature Sensor
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMT | Warmer, Infant Radiant |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K971695 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
797f3e80-1dba-49ed-a1b8-4cc357b49db6
July 06, 2018
3
September 08, 2016
July 06, 2018
3
September 08, 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 |
---|---|---|---|---|---|
09420012418845 | 20 | 09420012433145 | In Commercial Distribution | Pack |
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
[?]
1800 446 3908
Customer.CareUSA@fphcare.com
Customer.CareUSA@fphcare.com