TBL-ABI

Primary DI
B322C0011
Brand
TBL-ABI
Company
LD TECHNOLOGY, LLC
Model
C001
Device 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.
Published
2019-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173696000TBL-ABI SystemLd Technology, LLC2017-12-19JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B322C0011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a manually-inflated cuff that typically fits around a limb (arm or thigh). It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
305-379-9900albert.ldteck@gmail.com

Regulatory Flags#

DUNS number
079443785
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B322H0011LD-EKGH0012024-03-05
B322A0011SweatCA0012019-03-12
B322B0011TM-Oxi SystemB0012019-01-16
B322E0011BP-BT Lifeprobes Kiosk E0012024-03-05
B322F0011ES-BC F0012024-03-05
B322G0011ANS1 SoftwareG0012024-03-05
B322D0011LD-OxyD0012019-01-16

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