AffloVest

GUDID 00816305024043

AffloVest, Extra-Extra-Large

TACTILE SYSTEMS TECHNOLOGY, INC.

Chest-percussion airway secretion-clearing system

• Primary Device ID: 00816305024043
• NIH Device Record Key: 41cdd242-d486-4b79-9ea4-55b251a4daec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AffloVest
• Version Model Number: 8300XXL
• Company DUNS: 146295980
• Company Name: TACTILE SYSTEMS TECHNOLOGY, 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816305024043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122480

FDA Product Code

• BYI: Percussor, Powered-Electric

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: 2022-05-16
• Device Publish Date: 2022-05-08

On-Brand Devices [AffloVest]

• 00816305024128: AffloVest, Small (Warranty Repair)
• 00816305024111: AffloVest, Extra-Small (Warranty Repair)
• 00816305024104: AffloVest, Extra-Extra-Small (Warranty Repair)
• 00816305024098: AffloVest, Medium (Warranty Repair)
• 00816305024081: AffloVest, Large (Warranty Repair)
• 00816305024074: AffloVest, Extra-Large (Warranty Repair)
• 00816305024067: AffloVest, Extra-Extra-Large (Warranty Repair)
• 00816305024043: AffloVest, Extra-Extra-Large
• 00816305024036: AffloVest, Extra-Large
• 00816305024029: AffloVest, Large
• 00816305024012: AffloVest, Medium
• 00816305024005: AffloVest, Small
• 00816305023992: AffloVest, Extra-Small
• 00816305023985: AffloVest, Extra-Extra-Small
• 00816305023749: AffloVest Power Supply 18V 65W With USA Power Cord
• 00816305023732: AffloVest Battery 4S2P With Fuel Gage
• 00816305023725: AffloVest 12V Car Power Inverter
• 00816305023718: AffloVest Go Anywhere Case
• 00816305024487: DEMO AffloVest Extra Extra Extra Large Vest
• 00816305024470: DEMO AffloVest Extra Extra Large Vest
• 00816305024463: DEMO AffloVest Extra Large Vest
• 00816305024456: DEMO AffloVest Large Vest
• 00816305024449: DEMO AffloVest Medium Vest
• 00816305024432: DEMO AffloVest Small Vest
• 00816305024425: DEMO AffloVest Extra Small Vest
• 00816305024418: DEMO AffloVest Extra Extra Small Vest
• 00816305024500: AffloVest Extra-Extra-Extra Large Warranty Repair
• 00816305024364: Afflovest Extra-Extra-Extra-Large