Neonatal flow sensor ISO15

GUDID 04048675000099

Drägerwerk AG & Co. KGaA

Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable Breathing circuit gas-flow sensor, reusable

• Primary Device ID: 04048675000099
• NIH Device Record Key: ac0d1030-cba4-4ffe-849e-1d1639c57085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal flow sensor ISO15
• Version Model Number: 8411130
• Company DUNS: 315578914
• Company Name: Drägerwerk AG & Co. KGaA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	04048675000099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974176

FDA Product Code

• BXP: Transducer, Gas Flow
• CBK: Ventilator, Continuous, Facility Use

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: 2022-04-18
• Device Publish Date: 2022-04-08

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