DEVICE: NATUS NEUROLOGY (00382830028257)
Device Identifier (DI) Information
NATUS NEUROLOGY
X1F011
In Commercial Distribution
NATUS NEUROLOGY INCORPORATED
X1F011
In Commercial Distribution
NATUS NEUROLOGY INCORPORATED
IR PROBE 5 MHZ, CE MARK
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Noninvasive vascular ultrasound system probe | A hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNG | Monitor, Ultrasonic, Fetal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K944196 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5fc78e80-5d57-4564-95fa-6219bce1329e
July 06, 2018
3
September 15, 2016
July 06, 2018
3
September 15, 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 |
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No Package DIs found |
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
[?]
No Customer Contact currently defined