LD-EKG

Primary DI
B322H0011
Brand
LD-EKG
Company
LD TECHNOLOGY, LLC
Model
H001
Device description
Replacement blood pressure TBL-ABI: 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
2024-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B322H0011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electrocardiographicA small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.

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
B322A0011SweatCA0012019-03-12
B322B0011TM-Oxi SystemB0012019-01-16
B322E0011BP-BT Lifeprobes Kiosk E0012024-03-05
B322F0011ES-BC F0012024-03-05
B322G0011ANS1 SoftwareG0012024-03-05
B322C0011TBL-ABIC0012019-01-16
B322D0011LD-OxyD0012019-01-16

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