Go-PAP

Basic Information

• Brand Name: Go-PAP
• Primary DI: 00841470111601
• Version / Model: 313-4600
• Company Name: PULMODYNE INC
• Labeler DUNS: 030619483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-12
• Public Version: 1
• Public Version Date: 2025-04-21
• Public Version Status: New
• Public Device Record Key: 864a2d0e-25fa-410b-848a-d4a92d9ff6f4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	868.5965	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64811	In-line CPAP gas flow management unit, non-adjustable	A portable non-electronic device intended to mix ambient air with compressed oxygen (O2) to generate a flow of oxygen rich air to a patient at a pre-set (non-adjustable) inspired oxygen concentration (FiO2) [e.g., pre-set at 28-33%], for continuous positive airway pressure (CPAP) with oxygen, during noninvasive and invasive ventilation (i.e., capable of both). Also known as a CPAP flow generator, it includes an oxygen supply connection, ambient air inlet, and a patient outlet; it does not include any controls. CPAP pressure is defined by the PEEP valve used with this device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10841470111608	GS1		10	In Commercial Distribution
Primary	00841470111601	GS1