Zyppah ZCA-100-04

GUDID 00866868000343

Hybrid oral appliance, red / white / blue version

A.M.A. PLASTICS

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00866868000343
• NIH Device Record Key: 897fad10-7f30-468c-9300-2cc87bff1ff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyppah
• Version Model Number: Red-White-Blue
• Catalog Number: ZCA-100-04
• Company DUNS: 064454531
• Company Name: A.M.A. PLASTICS
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 800-875-3370
• Email: wecare@zyppah.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866868000343 [Primary]

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2018-03-29
• Device Publish Date: 2017-04-10

On-Brand Devices [Zyppah]

• 00866868000381: Edge to Edge
• 00866868000343: Hybrid oral appliance, red / white / blue version
• 00866868000336: Hybrid oral appliance, marbled pink / pink / white version
• 00866868000329: Hybrid oral appliance, pink version
• 00866868000312: Hybrid oral appliance, grey / green version
• 00866868000305: Hybrid oral appliance, camouflage version