O2-CPAP Valve

GUDID 10841470111035

PULMODYNE INC

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• Primary Device ID: 10841470111035
• NIH Device Record Key: a4426c43-7bc7-43df-87ad-313904319e6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2-CPAP Valve
• Version Model Number: 313-7717
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470111038 [Primary]
GS1	10841470111035 [Package]; Contains: 00841470111038; 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: 1
• Public Version Date: 2020-12-11
• Device Publish Date: 2020-12-03

Devices Manufactured by PULMODYNE INC

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• 10841470100749 - VT Select: 2023-04-18
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• 10841470100794 - VT Select: 2023-04-18
• 10841470100817 - VT Select: 2023-04-18
• 10841470106505 - BiTrac SE Select: 2022-04-05
• 10841470100282 - DART: 2022-04-04
• 10841470100299 - DART: 2022-04-04