GO-PAP

GUDID 10841470108288

PULMODYNE INC

Respiratory oxygen therapy system

• Primary Device ID: 10841470108288
• NIH Device Record Key: 900c93fb-f7b2-4196-abfd-b6a05c66a59a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GO-PAP
• Version Model Number: 313-4603N
• 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

Customer Support Contacts

• Phone: 317-246-5500
• Email: info@pulmodyne.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470108281 [Primary]
GS1	10841470108288 [Package]; Contains: 00841470108281; Package: [10 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-11
• Device Publish Date: 2017-03-31

On-Brand Devices [GO-PAP]

• 10841470111585: 313-4604N
• 10841470108288: 313-4603N
• 10841470108271: 313-4603
• 10841470108264: 313-4601N
• 10841470108257: 313-4601
• 10841470108240: 313-4602
• 10841470108233: 313-4602N
• 10841470111790: 313-4604
• 10841470111608: 313-4600
• 10841470111592: 313-4605N
• 10841470111516: 313-4605NC
• 10841470111509: 313-4604NC
• 10841470111493: 313-4603NC
• 10841470111486: 313-4602NC