Disposable PEP Devices

GUDID 00709078008825

PEP Accessory Kit

WESTMED, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00709078008825
• NIH Device Record Key: fa1363a2-c939-4994-a632-bef769f00383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable PEP Devices
• Version Model Number: 0262
• 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: false
• 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	00709078008825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955047

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-10
• Device Publish Date: 2020-07-31

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