ViSi 94-10174

GUDID 00850733007353

Disposable Wrist Cradle, Large (Qty 20)

SOTERA WIRELESS, INC.

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: 00850733007353
• NIH Device Record Key: 2de31ae5-5732-4270-85be-c94b6b0b3784
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViSi
• Version Model Number: Disposable Wrist Cradle, Large (Qty 20)
• Catalog Number: 94-10174
• Company DUNS: 167142491
• Company Name: SOTERA WIRELESS, INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850733007353 [Unit of Use]
GS1	00850733007360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152341

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-02
• Device Publish Date: 2020-06-24

On-Brand Devices [ViSi]

• 00850733007094: The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers
• 00850733007087: The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers
• 00850733007070: ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu
• 00850733007063: ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu
• 00850733007056: ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu
• 00850733007049: ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measu
• 10850733007039: ViSi NIBP Adapter is an accessory intended to connect ViSi Cuff Module with a non-ViSi NIBP Cuff
• 00850733007025: The ViSi thumb sensor is an accessory intended to use together with the ViSi Mobile Monitor to m
• 00850733007018: ViSi Cuff Module is an accessory intended for use together with the ViSi Mobile Monitor to measu
• 00850733007001: The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified pers
• 10850733007305: Chest Sensor Securements, 3M
• 00850733007186: Thumb Tape (Qty 100)
• 00850733007414: ViSi Emergency Medical Surveillance (EMS) Kit
• 00850733007407: Chest Sensor Securements (Qty 100)
• 00850733007384: ViSi Mobile Charger, 8-Bay
• 00850733007377: ViSi Mobile Charger, 2-Bay
• 00850733007353: Disposable Wrist Cradle, Large (Qty 20)
• 00850733007339: Disposable Wrist Cradle, Medium (Qty 20)
• 00850733007315: Disposable Wrist Cradle, Small (Qty 20)
• 00850733007278: Disposable Adult Cuff, Large+ (Qty 20)
• 00850733007254: Disposable Adult Cuff, Large (Qty 20)
• 00850733007230: Disposable Adult Cuff, Medium+ (Qty 20)
• 00850733007216: Disposable Adult Cuff, Medium (Qty 20)
• 00850733007193: Disposable Adult Cuff, Small (Qty 20)
• 00850733007162: Thumb Wrap (Qty 100)
• 00850733007155: ViSi Mobile Cuff Module, Refurbished
• 00850733007148: Reusable cNIBP & SpO2 Thumb Sensor