ESA 615 4132164

GUDID 00850540007034

Electrical Safety Analyzer

FLUKE ELECTRONICS CORPORATION

Electrical safety tester

• Primary Device ID: 00850540007034
• NIH Device Record Key: d22feff6-98bf-43a6-baff-30a0f3b60f56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESA 615
• Version Model Number: ESA615-10-NA220
• Catalog Number: 4132164
• Company DUNS: 002687614
• Company Name: FLUKE ELECTRONICS CORPORATION
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850540007034 [Primary]

FDA Product Code

• DRT: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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: 2018-06-25
• Device Publish Date: 2018-05-24

On-Brand Devices [ESA 615]

• 00850540007034: Electrical Safety Analyzer
• 00850540007027: Electrical Safety Analyzer