FDA.reportPublic FDA data

ViSi

Primary DI
00850733007162
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
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
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
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, 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 is not hypoallergenic or waterproof. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
167142491
Device count
100
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
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