AffloVest

GUDID 00814321020032

The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motors organized into zones. The vest may be run on battery or A/C power from a standard wall outlet. The AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician’s choice of treatment.

INTERNATIONAL BIOPHYSICS CORPORATION

Chest-oscillation airway secretion-clearing system

• Primary Device ID: 00814321020032
• NIH Device Record Key: 56758636-5974-42b3-926a-ca46eea0efca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AffloVest
• Version Model Number: 8100XS
• Company DUNS: 788403103
• Company Name: INTERNATIONAL BIOPHYSICS CORPORATION
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814321020032 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-24

On-Brand Devices [AffloVest]

• 00814321020087: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory moto
• 00814321020070: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory moto
• 00814321020063: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory moto
• 00814321020056: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory moto
• 00814321020049: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory moto
• 00814321020032: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory moto
• 00814321020025: The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory moto