Pneupac

GUDID 35019315071892

Smiths Medical International Ltd

Neonatal intensive-care ventilator

• Primary Device ID: 35019315071892
• NIH Device Record Key: e84e71fb-c385-418f-94b2-0ebe681f7def
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneupac
• Version Model Number: B100NUS
• Company DUNS: 215590304
• Company Name: Smiths Medical International Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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	35019315071892 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-12

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