FDA.reportPublic FDA data

Pressure Cuff Size 12L

Primary DI
07290016880489
Brand
Pressure Cuff Size 12L
Company
VIASONIX LTD
Model
Pressure Cuff Size 12L
Device description
The intended use of the pressure cuffs is to measure non-invasively blood pressure
Published
2023-06-29
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
JOPTransducer, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOPTransducer, UltrasonicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111416000FALCONViasonix , Ltd.2011-07-15JOP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016880489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016880489072900168804897290016880489

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533070236
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
072900168803974 MHz probe 4 MHz probePVC03302022-08-08
072900168804038 MHz probe 8 MHz probePVC03312022-08-08
07290016880540DolphinXpress2025-11-20
0729001688041010 MHz probe 10 MHz probePVC03322022-08-08
07290016880441Detachable PPG Clip sensorDetachable PPG Clip sensor2024-12-27
07290016880533Falcon/XpressFalcon/Xpress2024-12-27
07290016880496Pressure Cuff Size 2.5Pressure Cuff Size 2.52023-06-29
07290016880502Pressure Cuff Size 1.9Pressure Cuff Size 1.92023-06-29
07290016880519Pressure Cuff Size 1.6Pressure Cuff Size 1.62023-06-29
07290016880526Pressure Cuff Size 7Pressure Cuff Size 72023-06-29
07290016880465Pressure Cuff Size 10Pressure Cuff Size 102023-06-23
07290016880472Pressure Cuff Size 12Pressure Cuff Size 122023-06-25
07290016880229Dolphin/XF Robot AccessoryDolphin/XF Robot Accessory2021-03-31
0729001688007610 MHz probe 10 MHz probe2020-06-19
07290016880168Toe Clip PPG Sensor Toe Clip PPG Sensor PVC01432020-06-19
07290016880175Disk PPG sensor Disk PPG sensor 2020-06-19
07290016880182Fingerclip PPG sensor Fingerclip PPG sensor 2020-06-19
07290016880250LiteWalkLiteWalk2020-06-19
07290016880267LiteWalk SandalsLargePVC0268-L2020-06-19
07290016880274LiteWalk SandalsMediumPVC0268-M2020-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029536CooperSurgical® Coopersurgical, Inc.JOP2026-04-10
G677H1V06VasoGuardCorVascularJOP2026-04-08
G677H1V08VasoGuardCorVascularJOP2026-04-08
G677H1V10VasoGuardCorVascularJOP2026-04-08
G677H2V02VasoGuardCorVascularJOP2026-04-08
G677H2V04VasoGuardCorVascularJOP2026-04-08
G677VG0201VasoGuardCorVascularJOP2026-04-08
G677VG0401VasoGuardCorVascularJOP2026-04-08
G677VG0601VasoGuardCorVascularJOP2026-04-08
G677VG0801VasoGuardCorVascularJOP2026-04-08
G677VG1001VasoGuardCorVascularJOP2026-04-08
00888937027815CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027808CooperSurgical® Coopersurgical, Inc.JOP2026-01-23
00888937027822CooperSurgical® Coopersurgical, Inc.JOP2025-09-25
07290016880441Detachable PPG Clip sensorVIASONIX LTDJOP2024-12-27
07290016880533Falcon/XpressVIASONIX LTDJOP2024-12-27
07290016880496Pressure Cuff Size 2.5VIASONIX LTDJOP2023-06-29
07290016880502Pressure Cuff Size 1.9VIASONIX LTDJOP2023-06-29
07290016880519Pressure Cuff Size 1.6VIASONIX LTDJOP2023-06-29
07290016880526Pressure Cuff Size 7VIASONIX LTDJOP2023-06-29
07290016880472Pressure Cuff Size 12VIASONIX LTDJOP2023-06-25
07290016880465Pressure Cuff Size 10VIASONIX LTDJOP2023-06-23
072900168803974 MHz probe VIASONIX LTDJOP2022-08-08
072900168804038 MHz probe VIASONIX LTDJOP2022-08-08
0729001688041010 MHz probe VIASONIX LTDJOP2022-08-08
008167870243193.9MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243268.1MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243408.7MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15