O2-CPAP

GUDID 10841470111028

PULMODYNE INC

PEEP valve, single-use

• Primary Device ID: 10841470111028
• NIH Device Record Key: 124255dd-f8c4-4c85-a7e4-7b9c1da64ff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2-CPAP
• Version Model Number: 313-7716
• Company DUNS: 030619483
• Company Name: PULMODYNE 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470111021 [Primary]
GS1	10841470111028 [Package]; Contains: 00841470111021; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983920

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-30

On-Brand Devices [O2-CPAP]

• 10841470111066: 313-7718
• 10841470111059: 313-7720
• 10841470111042: 313-7719
• 10841470111028: 313-7716
• 10841470111011: 313-7715
• 10841470111004: 313-7730
• 10841470110991: 313-7725
• 10841470110984: 313-7721