Pneupac

GUDID 35019315107263

Smiths Medical International Ltd

Transport electric ventilator

• Primary Device ID: 35019315107263
• NIH Device Record Key: abdff932-16b3-49a5-8389-95cf5118b9cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pneupac
• Version Model Number: P310NUS
• 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: true
• 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	35019315107263 [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