Pneupac

GUDID 15019517181173

Smiths Medical ASD, Inc.

Neonatal intensive-care ventilator

• Primary Device ID: 15019517181173
• NIH Device Record Key: 67ffff5b-1f1c-4951-8e25-0f5ac29f3551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneupac
• Version Model Number: 510A1960NONEU
• Company DUNS: 082005361
• Company Name: Smiths Medical ASD, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517181173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043495

FDA Product Code

• BTL: Ventilator, emergency, powered (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: 2019-05-03
• Device Publish Date: 2019-04-25

On-Brand Devices [Pneupac]

• 15019517181173: 510A1960NONEU
• 15019517180367: 530A1166NONEU
• 15019517189513: 520A1125NONEU
• 15019517180381: 530A1167NFRNONEU
• 15019517180374: 530A1166NFRNONEU