ANS1 Software

GUDID B322G0011

"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management. The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."

LD TECHNOLOGY, LLC

Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable Manual-inflation electronic sphygmomanometer, non-portable
Primary Device IDB322G0011
NIH Device Record Keyeefb6530-ad18-4713-85ac-2cfbe297291f
Commercial Distribution StatusIn Commercial Distribution
Brand NameANS1 Software
Version Model NumberG001
Company DUNS079443785
Company NameLD TECHNOLOGY, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com
Phone305-379-9900
Emailalbert.ldteck@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB322G0011 [Primary]

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-13
Device Publish Date2024-03-05

Devices Manufactured by LD TECHNOLOGY, LLC

B322E0011 - BP-BT Lifeprobes Kiosk 2024-03-13 "BP-BT Kiosk is designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumfer
B322F0011 - ES-BC 2024-03-13 EC-BC indication for use: Claculation and historical tracking of : Actual resistance, actual reactance, actual impedance, actual
B322G0011 - ANS1 Software2024-03-13"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management. The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."
B322G0011 - ANS1 Software2024-03-13 "ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with data
B322H0011 - LD-EKG2024-03-13 "LD EKG is intended for use: The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical acti
B322B0011 - TM-Oxi System2019-11-08 The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying fun
B322C0011 - TBL-ABI2019-11-08 The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is
B322A0011 - SweatC2019-06-07 SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
B322D0011 - LD-Oxy2019-02-18 To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoel
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