ReddyPort

GUDID 10850001175217

24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.

SMD Manufacturing LLC

Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use

• Primary Device ID: 10850001175217
• NIH Device Record Key: c77594b1-23a6-4f15-8d4d-99b759c9f3e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReddyPort
• Version Model Number: RP-MKITQ4-1
• Company DUNS: 070849038
• Company Name: SMD Manufacturing 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: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001175210 [Primary]
GS1	10850001175217 [Package]; Contains: 00850001175210; Package: Case [10 Units]; In Commercial Distribution
NDC/NHRIC	73573-155-14 [Secondary]

FDA Product Code

• KXF: Applicator, Absorbent Tipped, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-09
• Device Publish Date: 2020-11-18

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