FDA.reportPublic FDA data

ViSi

Primary DI
00850733007230
Brand
ViSi
Company
SOTERA WIRELESS, INC.
Model
Disposable Adult Cuff, Medium+ (Qty 20)
Catalog number
94-10191
Device description
Disposable Adult Cuff, Medium+ (Qty 20)
Published
2020-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152341000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152341000ViSi Mobile Monitoring SystemSotera Wireless, Inc.2015-12-14MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850733007247PrimaryGS10
00850733007230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850733007247008507330072478507330072470850733007247
00850733007230008507330072308507330072300850733007230

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, single-useA 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 typically wrapped around the upper arm of the patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
167142491
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850733007183ViSiThumb Tape (Qty 100)94-100072020-06-24
00850733007032ViSiNIBP Adapter2016-09-19
00850733007179ViSiThumb Wrap (Qty 100)93-100212020-06-24
00850733007209ViSiDisposable Adult Cuff, Small (Qty 20)94-101892020-06-24
00850733007223ViSiDisposable Adult Cuff, Medium (Qty 20)94-101902020-06-24
00850733007247ViSiDisposable Adult Cuff, Medium+ (Qty 20)94-101912020-06-24
00850733007261ViSiDisposable Adult Cuff, Large (Qty 20)94-101922020-06-24
00850733007285ViSiDisposable Adult Cuff, Large+ (Qty 20)94-101932020-06-24
00850733007322ViSiDisposable Wrist Cradle, Small (Qty 20)94-101722020-06-24
00850733007346ViSiDisposable Wrist Cradle, Medium (Qty 20)94-101732020-06-24
00850733007360ViSiDisposable Wrist Cradle, Large (Qty 20)94-101742020-06-24
00850733007148ViSiReusable cNIBP & SpO2 Thumb Sensor93-101292020-06-24
00850733007155ViSiViSi Mobile Cuff Module, Refurbished93-101472020-06-24
00850733007377ViSiViSi Mobile Charger, 2-Bay92-100222020-06-24
00850733007384ViSiViSi Mobile Charger, 8-Bay92-100232020-06-24
00850733007407ViSiChest Sensor Securements (Qty 100)94-101952020-06-24
00850733007414ViSiViSi Emergency Medical Surveillance (EMS) Kit97-102592020-06-24
10850733007305ViSiChest Sensor Securements, 3M (Qty 100)94-100122020-06-24
00850733007001ViSiMobile Monitor92-100102016-09-19
00850733007018ViSiCuff Module92-100112016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27