Pneupac

GUDID 10610586045523

SMITHS MEDICAL MD, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 10610586045523
• NIH Device Record Key: f28bebd8-027a-4b05-9385-7cc7c77bfddd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneupac
• Version Model Number: 123000
• Company DUNS: 106712748
• Company Name: SMITHS MEDICAL MD, 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: false
• 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	10610586045523 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2015-09-01

On-Brand Devices [Pneupac]

• 30610586045749: WW122006
• 30610586045558: 124003
• 10610586045547: 123004
• 10610586045530: 123001
• 10610586045523: 123000
• 10610586045516: 122203
• 10610586045509: 122202
• 30610586038284: 122004