AffloVest

GUDID 00814321020025

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 ID00814321020025
NIH Device Record Key4ae08e67-2816-47fd-9b8c-9f3ca64b15e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffloVest
Version Model Number8100
Company DUNS788403103
Company NameINTERNATIONAL BIOPHYSICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814321020025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYIPercussor, Powered-Electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-24

On-Brand Devices [AffloVest]

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

Trademark Results [AffloVest]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFLOVEST
AFFLOVEST
85930648 4589749 Live/Registered
International Biophysics Corporation
2013-05-13

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