Babi.Plus 12.5 cmH O Pressure Relief Manifold

GUDID 44710810093560

GALEMED CORPORATION

Ventilator IMV supplemental circuit, single-use

• Primary Device ID: 44710810093560
• NIH Device Record Key: 54c943cd-f318-4d23-855c-9374abc5961e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Babi.Plus
• Version Model Number: BC23-AU
• Catalog Number: 12.5 cmH O Pressure Relief Manifold
• 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: false
• 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	04710810093562 [Primary]
GS1	44710810093560 [Package]; Contains: 04710810093562; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110383

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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 [Babi.Plus]

• 44710810093577: BC01-AU
• 44710810119741: B024
• 44710810119734: B023
• 44710810119727: B022
• 44710810119710: B021
• 44710810119703: B020
• 44710810100800: Distributed by Teleflex
• 44710810100794: Distributed by Teleflex
• 04710810093579: BC01-AU
• 44710810093560: BC23-AU
• 44710810117525: PA01
• 44710810093553: BC51-AU
• 04710810105265: BC01-AU