DEVICE: DOPPLEX (05051968021281)
Device Identifier (DI) Information
DOPPLEX
MD2-P
In Commercial Distribution
MD2-P-USA
HUNTLEIGH HEALTHCARE LIMITED
MD2-P
In Commercial Distribution
MD2-P-USA
HUNTLEIGH HEALTHCARE LIMITED
MULTI DOPPLEX II POCKET,USA
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
34040 | Foetal Doppler system |
A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNG | Monitor, Ultrasonic, Fetal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K930200 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 10 and 30 Degrees Celsius |
Storage Environment Temperature: between -10 and 40 Degrees Celsius |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Humidity: less than 93 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 860 and 1060 millibar |
Storage Environment Atmospheric Pressure: between 860 and 1060 millibar |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
557a67ce-3926-4454-be31-0c69e262b4ab
July 06, 2018
3
August 22, 2016
July 06, 2018
3
August 22, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+4402920485885
sales@huntleigh-diagnostics.co.uk
sales@huntleigh-diagnostics.co.uk