BagEasy

GUDID 20709078620847

Infant Resuscitator w/Peep and Mask

WESTMED, INC.

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

• Primary Device ID: 20709078620847
• NIH Device Record Key: ada661fd-607b-4e5b-a0d9-290fd90ee0c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BagEasy
• Version Model Number: 562084
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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: 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	00709078620843 [Primary]
GS1	20709078620847 [Package]; Contains: 00709078620843; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940581

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: 2015-10-24

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