FDA.reportPublic FDA data

ViSi

Primary DI
00850733007179
Brand
ViSi
Company
Sotera Wireless, Inc.
Model
Thumb Wrap (Qty 100)
Catalog number
93-10021
Device description
Thumb Wrap (Qty 100)
Published
2020-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

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
00850733007179PrimaryGS10
00850733007162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850733007179008507330071798507330071790850733007179
00850733007162008507330071628507330071620850733007162

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Regulatory Flags#

DUNS number
167142491
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850733007183ViSiThumb Tape (Qty 100)94-100072020-06-24
00850733007032ViSiNIBP Adapter2016-09-19
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
00850733007025ViSiThumb Sensor92-100202016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09