Affinity Cable and Leadwire System

GUDID 00850384007009

AFFINITY MEDICAL TECHNOLOGIES, LLC

Electrocardiographic lead set, reusable

• Primary Device ID: 00850384007009
• NIH Device Record Key: a84069ec-bb5c-4fa1-9cd2-598f8f7a6192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity Cable and Leadwire System
• Version Model Number: 394111-009
• Company DUNS: 088091038
• Company Name: AFFINITY MEDICAL TECHNOLOGIES, LLC
• Device Count: 1
• 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: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850384007009 [Primary]

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Affinity Cable and Leadwire System]

• 00850384007115: T097-1 DTX
• 00850384007108: T099-1 DTX
• 00850384007085: 453561432691
• 00850384007054: 394111-014
• 00850384007047: 394111-013
• 00850384007030: 394111-012
• 00850384007023: 394111-011
• 00850384007016: 394111-010
• 00850384007009: 394111-009