TBL-ABI

GUDID B322C0011

The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TBL-ABI can be used on patients with unilateral lower limb amputation.

LD TECHNOLOGY, LLC

Manual-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: B322C0011
• NIH Device Record Key: d2d62463-6ef5-435b-bb28-d9bd607feb25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TBL-ABI
• Version Model Number: C001
• Company DUNS: 079443785
• Company Name: LD TECHNOLOGY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 305-379-9900
• Email: albert.ldteck@gmail.com
• Phone: 305-379-9900
• Email: albert.ldteck@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B322C0011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173696

FDA Product Code

• JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-16

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• B322C0011 - TBL-ABI: 2019-11-08The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy. TBL-ABI can be used on patients with unilateral lower limb amputation.
• B322C0011 - TBL-ABI: 2019-11-08 The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is
• B322A0011 - SweatC: 2019-06-07 SudoC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
• B322D0011 - LD-Oxy: 2019-02-18 To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoel