Curaplex® SGOPAPMD02-24-KIT

GUDID 00810094579272

Curaplex GO-PAP/Capno Kit (GO-PAP Neb, Adult MD mask, Neb-Connect, CO2 Sampling Line)

BOUND TREE MEDICAL, LLC

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 00810094579272
• NIH Device Record Key: 27ba7978-6b91-4d3e-b144-e5c4c14284b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curaplex®
• Version Model Number: SGOPAPMD02-24-KIT
• Catalog Number: SGOPAPMD02-24-KIT
• Company DUNS: 070556204
• Company Name: BOUND TREE MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810094578046 [Primary]
GS1	00810094579272 [Package]; Contains: 00810094578046; Package: CS [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-17
• Device Publish Date: 2025-07-09

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