RELIEVA VORTEX 2 RV02

GUDID 20705031205878

RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER

ACCLARENT, INC.

Paranasal sinus irrigation catheter

• Primary Device ID: 20705031205878
• NIH Device Record Key: c55e7b4a-8705-4b8a-a9eb-1889ab955862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIEVA VORTEX 2
• Version Model Number: RV02
• Catalog Number: RV02
• Company DUNS: 361092450
• Company Name: ACCLARENT, INC.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: +1(877)775-2789
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031205871 [Primary]
GS1	20705031205878 [Package]; Contains: 10705031205871; Package: BOX [5 Units]; In Commercial Distribution

FDA Product Code

• KAR: IRRIGATOR, SINUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-10-01

On-Brand Devices [RELIEVA VORTEX 2]

• 20705031205885: RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER, 1 PK
• 20705031205878: RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER