Novaplus

GUDID 35019315052501

Smiths Medical International Ltd

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use

• Primary Device ID: 35019315052501
• NIH Device Record Key: 7c01fc66-7e69-46f7-aef4-b553d5a499b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novaplus
• Version Model Number: V8500
• Company DUNS: 215590304
• Company Name: Smiths Medical International Ltd
• 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: 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	15019315052507 [Primary]
GS1	35019315052501 [Package]; Contains: 15019315052507; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014115

FDA Product Code

• BTM: Ventilator, emergency, manual (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: 2015-08-19

On-Brand Devices [Novaplus]

• 35019315052501: V8500
• 35019315049495: V8503C
• 35019315049488: V8503