Pneupac

GUDID 35019315107478

Smiths Medical International Ltd

Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator Transport electric ventilator

• Primary Device ID: 35019315107478
• NIH Device Record Key: 673247ff-b184-4085-818b-6e98fbe2b953
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneupac
• Version Model Number: 530A1167
• Company DUNS: 215590304
• Company Name: Smiths Medical International Ltd
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	35019315107478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123957

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-01

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