ETG-4000

GUDID 04573596203439

FUJIFILM HEALTHCARE CORPORATION

Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered Pulse oximeter, line-powered

• Primary Device ID: 04573596203439
• NIH Device Record Key: 2baca765-5b5e-473c-8d0d-6b4c4ac6c90b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETG-4000
• Version Model Number: ETG-4000
• Company DUNS: 718262719
• Company Name: FUJIFILM HEALTHCARE 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: true
• 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	04573596203439 [Primary]
GS1	04580292776150 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042501

FDA Product Code

• DQA: Oximeter

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: 2021-07-22
• Device Publish Date: 2021-07-14

Devices Manufactured by FUJIFILM HEALTHCARE CORPORATION

• 04573596212011 - L31KP: 2024-02-02 Probe
• 04573596212318 - S3ESCLS: 2024-02-02 Probe
• 04573596212035 - L35: 2024-01-30 Probe
• 04573596212455 - UST-2266-5: 2024-01-30 Probe
• 04573596214176 - CL4416R1: 2024-01-30 Probe
• 04573596214336 - C421: 2024-01-30 Probe
• 04573596214503 - CC41R2: 2024-01-30 Probe
• 04573596214510 - C253A: 2024-01-30 Probe