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Tbl-Abi

FDA UDI

Class II (US FDA UDI)

by Ld Technology Llc

Identity

Trade Name
TBL-ABI FDA UDI
Generic Name
Manual-inflation electronic sphygmomanometer, non-portable FDA UDI
Device Name
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. FDA UDI
Model / Reference
C001 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B322C0011 FDA UDI
510(k) Number
K173696 FDA UDI
FDA Product Code
JOM FDA UDI
GMDN Term
Manual-inflation electronic sphygmomanometer, non-portable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Manual-inflation electronic sphygmomanometer, non-portable

Tbl-Abi by Ld Technology Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual-inflation electronic sphygmomanometer, non-portable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ld Technology Llc

Sources (1)

  • FDA UDI d2d62463-6ef5-435b-bb28-d9bd607feb25 35 fields · synced Jun 1, 2026