Winx® W1000-00

GUDID 00852126007001

Winx Sleep Apnea Therapy System, Packaged

APNICURE, INC.

General-purpose suction system, line-powered

• Primary Device ID: 00852126007001
• NIH Device Record Key: 1dc19d42-d0e0-47b1-a043-4f469b81ba7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Winx®
• Version Model Number: W1000-00
• Catalog Number: W1000-00
• Company DUNS: 008873230
• Company Name: APNICURE, INC.
• 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: true
• Manufacturing Date: true
• 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: 888 986 6275
• Email: poconnor@apnicure.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852126007001 [Primary]

FDA Product Code

• OZR: Intraoral Pressure Gradient Device

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: 2016-09-16

On-Brand Devices [Winx®]

• 00852126007544: Winx Warranty Console
• 00852126007537: Winx Disposable Kit
• 00852126007520: Winx Sizing Template kit
• 00852126007513: Winx Sleep Lab Console Kit
• 00852126007506: Winx Data Management Software on USB Drive
• 00852126007490: Winx Vacuum Test Loop
• 00852126007483: Winx Sleep Lab Disposable Kit
• 00852126007476: Winx Bite Wax Kit
• 00852126007469: Winx FB Trial Mouthpiece with Tubing, L4
• 00852126007452: Winx FB Trial Mouthpiece with Tubing, L3
• 00852126007445: Winx FB Trial Mouthpiece with Tubing, L2
• 00852126007438: Winx FB Trial Mouthpiece with Tubing, M4
• 00852126007421: Winx FB Trial Mouthpiece with Tubing, M3
• 00852126007414: Winx FB Trial Mouthpiece with Tubing, M2
• 00852126007407: Winx FB Trial Mouthpiece with Tubing, M1
• 00852126007391: Winx FB Trial Mouthpiece with Tubing, S3
• 00852126007384: Winx FB Trial Mouthpiece with Tubing, S2
• 00852126007377: Winx FB Trial Mouthpiece with Tubing, S1
• 00852126007360: Winx Mouthpiece Holder
• 00852126007353: Winx Power Cord
• 00852126007346: Winx Bite Profile Kit
• 00852126007339: O-ring Replacement Kit
• 00852126007322: Winx Tubing Set
• 00852126007315: Winx Reservoir, Packaged
• 00852126007308: Winx HB Mouthpiece, L4
• 00852126007292: Winx HB Mouthpiece, L3
• 00852126007285: Winx HB Mouthpiece, L2
• 00852126007278: Winx HB Mouthpiece, M4
• 00852126007261: Winx HB Mouthpiece, M3
• 00852126007254: Winx HB Mouthpiece, M2
• 00852126007247: Winx HB Mouthpiece, M1
• 00852126007230: Winx HB Mouthpiece, S3
• 00852126007223: Winx HB Mouthpiece, S2
• 00852126007216: Winx HB Mouthpiece, S1
• 00852126007209: Winx+ Mouthpiece, L4
• 00852126007193: Winx+ Mouthpiece, L3
• 00852126007186: Winx+ Mouthpiece, L2
• 00852126007179: Winx+ Mouthpiece, M4
• 00852126007162: Winx+ Mouthpiece, M3
• 00852126007155: Winx+ Mouthpiece, M2
• 00852126007148: Winx+ Mouthpiece, M1
• 00852126007131: Winx+ Mouthpiece, S3
• 00852126007124: Winx+ Mouthpiece, S2
• 00852126007117: Winx+ Mouthpiece, S1
• 00852126007100: Winx FB Mouthpiece, L4
• 00852126007094: Winx FB Mouthpiece, L3
• 00852126007087: Winx FB Mouthpiece, L2
• 00852126007070: Winx FB Mouthpiece, M4
• 00852126007063: Winx FB Mouthpiece, M3
• 00852126007056: Winx FB Mouthpiece, M2