Spaulding Electrocardiograph

GUDID B441BTIEC0

The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device* collects and uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.

SPAULDING MEDICAL

Electrocardiograph, professional, multichannel

• Primary Device ID: B441BTIEC0
• NIH Device Record Key: f72defec-df04-4949-bf61-dcc0ccc59701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spaulding Electrocardiograph
• Version Model Number: 2100iQ
• Company DUNS: 116813644
• Company Name: SPAULDING MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com
• Phone: 18886077871
• Email: clientservices@spauldingclinical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B441BTIEC0 [Primary]

FDA Product Code

• DPS: Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-09
• Device Publish Date: 2017-03-16

On-Brand Devices [Spaulding Electrocardiograph]

• B441IQ0: The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG man
• B441BTIEC0: The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG man
• B441BTAHA0: The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG man