Pneupac

GUDID 10610586038259

ICU MEDICAL, INC.

Transport electric ventilator

• Primary Device ID: 10610586038259
• NIH Device Record Key: 63a084ca-fb0c-43da-8c6d-e3112bf3b2ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneupac
• Version Model Number: 130003
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10610586038259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030803

FDA Product Code

• BTL: Ventilator, emergency, powered (resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-04-16
• Device Publish Date: 2015-09-01

On-Brand Devices [Pneupac]

• 10610586045752: WW331002S
• 10610586045738: 520A1300US
• 10610586045721: 520A1299US
• 10610586045653: 150003V
• 10610586045622: 130002V
• 10610586045578: 150003
• 10610586045561: 130002
• 10610586045493: 122005
• 10610586045486: 120003
• 10610586045479: 120002
• 10610586038259: 130003
• 15019517189520: 520A1126NESNONEU