FENEM

GUDID 10841470108356

ENGINEERED MEDICAL SYSTEMS INC

Exhaled-gas oesophageal intubation detector, adult

• Primary Device ID: 10841470108356
• NIH Device Record Key: b4801a8f-f9cb-41c6-b48d-47cfe453dac9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FENEM
• Version Model Number: 301-5585
• Company DUNS: 154502934
• Company Name: ENGINEERED MEDICAL SYSTEMS INC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470108359 [Primary]
GS1	10841470108356 [Package]; Contains: 00841470108359; Package: [10 Units]; In Commercial Distribution
GS1	20841470108353 [Package]; Package: [120 Units]; In Commercial Distribution

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

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: 2023-12-20
• Device Publish Date: 2023-12-12

On-Brand Devices [FENEM]

• 10841470108370: 301-5534
• 10841470108356: 301-5585