FDA.reportPublic FDA data

Unetixs Vascular

Primary DI
B437129500
Brand
Unetixs Vascular
Company
UNETIXS VASCULAR, INC.
Model
Multilab 2000 Series 2 Revo
Catalog number
12950-0000-01
Device description
The Revo is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular system.
Published
2023-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAFMonitor, Ultrasonic, Nonfetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAFMonitor, Ultrasonic, NonfetalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904392000MULTILAB 2000Unetixs, Inc.1991-04-29JAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B437129500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Limb plethysmographA graphic recorder designed for determining and registering volume variations in the extremities (legs/toes and/or arms/fingers) as modified by the circulation of blood through them. It typically consists of flow and/or volume sensors and transducers attached to an electronic unit, which processes the data and displays the results. It may operate using one of several methods including venous occlusion (pneumatic), photoelectric, electrical impedance, or strain gauge. The device is typically used in peripheral vascular diagnostic investigations [e.g., for deep vein thrombosis (DVT) or arterial occlusive disease].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
625463146
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B4371194904Unetixs Vascular Multilab Series 2 LHS 11949-0000-012023-02-27
B4371198605Unetixs Vascular Multilab Series 2 LHS Roodra11986-0000-012023-02-27
B4371199606Unetixs Vascular Multilab Series 2 2CP11996-0000-012023-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067960010Imex ELITE 3MHZ OB PROBEIMEX, LLCJAF2026-05-18
00860011754565Imex ELITE 2MHZ WATERPROOF PROBE V2IMEX, LLCJAF2026-05-18
00860011754572Imex ELITE 2MHZ OB PROBEIMEX, LLCJAF2026-05-18
00860011754589Imex ELITE 8MHZ VASCULAR PROBEIMEX, LLCJAF2026-05-18
00860011754596Elite 5 MHz Vascular ProbeIMEX, LLCJAF2026-05-18
00860011754503Imex Elite 200 DopplerIMEX, LLCJAF2026-05-13
00860011754527Imex Elite 100 DopplerIMEX, LLCJAF2026-05-13
00860011754534Imex CT+ DopplerIMEX, LLCJAF2026-05-13
00860011754541Imex Elite 200R DopplerIMEX, LLCJAF2026-05-13
00860011754558Imex Elite 100R DopplerIMEX, LLCJAF2026-05-13
08033737710869THD SLIDE ONETHD SPAJAF2025-10-30
18033737710354THD SLIDE ONETHD SPAJAF2025-10-30
08051887047918THD SLIDE ONETHD SPAJAF2025-04-03
18051887047915THD SLIDE ONETHD SPAJAF2025-04-03
B4371194904Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371198605Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371199606Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
18033737710781THD SLIDE ONETHD SPAJAF2022-09-09
08033737710777THD SLIDE ONETHD SPAJAF2022-09-01
18033737710774THD SLIDE ONETHD SPAJAF2022-09-01
05051968044501DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJAF2022-02-07
00852785008289DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008296DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008340DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008357DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008401DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008418DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008463DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008470DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008494DigiDopNEWMAN MEDICAL LLCJAF2021-06-25