Pneupac

GUDID 35019517159664

Smiths Medical International Ltd

Ventilator breathing circuit, single-use

• Primary Device ID: 35019517159664
• NIH Device Record Key: 04a80aa6-517d-4fbc-a424-65356d4acb64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneupac
• Version Model Number: 100/905/320-CH
• Company DUNS: 215590304
• Company Name: Smiths Medical International Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019517159660 [Primary]
GS1	35019517159664 [Package]; Contains: 15019517159660; Package: Carton [10 Units]; In Commercial Distribution

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: 2020-05-14
• Device Publish Date: 2020-05-06

On-Brand Devices [Pneupac]

• 35019315107478: 530A1167
• 35019315107270: P300NUS
• 35019315107263: P310NUS
• 35019315074862: VR1AIRNUS
• 35019315074183: V200DNUS
• 35019315072738: P200DNUS
• 35019315071892: B100NUS
• 35019315071533: APH
• 35019517160219: 100/905/340-CH
• 35019517159602: 100/905/301-CH
• 35019517159121: 100/905/300-CH
• 45019315079215: 100/905/361
• 45019315079208: 100/905/360
• 35019315076118: 100/905/341
• 35019315076101: 100/905/340
• 35019517160226: 100/905/341-CH
• 10610586046063: 122003
• 10610586046056: 122002
• 35019517159664: 100/905/320-CH
• 35019517159640: 100/905/302-CH
• 15019517178845: 530A1167NONEU