ReddyPort

GUDID 10850001175002

Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1

SMD Manufacturing LLC

CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use

• Primary Device ID: 10850001175002
• NIH Device Record Key: 327384b2-aac6-4fb4-8ede-31d6b162e013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReddyPort
• Version Model Number: RP-531-L1
• Company DUNS: 070849038
• Company Name: SMD Manufacturing LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com
• Phone: +1 (801) 899-3036
• Email: info@reddyport.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001175005 [Primary]
GS1	10850001175002 [Package]; Contains: 00850001175005; Package: Box [10 Units]; In Commercial Distribution
GS1	20850001175009 [Package]; Package: Case [50 Units]; In Commercial Distribution
GS1	30850001175006 [Package]; Contains: 20850001175009; Package: Overshipper [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171827

FDA Product Code

• MNS: Ventilator, Continuous, Non-Life-Supporting

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: 2020-11-05
• Device Publish Date: 2020-10-28

On-Brand Devices [ReddyPort]

• 10850001175002: Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1
• 10850001175217: 24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1
• 10850001175224: ReddyPort 24-hour NIV Maintenance Kit follows Q4 protocols (every 4 hours) for standard oral car
• 10850001175071: ReddyPort Standard Elbow
• 10850001175064: ReddyPort Leak 2 Elbow
• 10850001175026: ReddyPort Leak 1 Elbow