Venti.Plus Hyperinflation System 0.5L with Mask

GUDID 44710810100497

GALEMED CORPORATION

Anaesthesia face mask, reusable

• Primary Device ID: 44710810100497
• NIH Device Record Key: f5b4814e-0d93-4444-b06e-6be04c30f2d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Venti.Plus
• Version Model Number: H050-M
• Catalog Number: Hyperinflation System 0.5L with Mask
• Company DUNS: 656854379
• Company Name: GALEMED CORPORATION
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710810100499 [Primary]
GS1	44710810100497 [Package]; Contains: 04710810100499; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092687

FDA Product Code

• NHK: Resuscitator,Manual,Non Self-Inflating

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: 2015-09-24

On-Brand Devices [Venti.Plus]

• 44710810117396: H100
• 44710810117389: H050
• 44710810117372: H025
• 44710810100503: H100-M
• 44710810100497: H050-M
• 44710810100480: H025-M