AffloVest

GUDID 00816305023985

AffloVest, Extra-Extra-Small

TACTILE SYSTEMS TECHNOLOGY, INC.

Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system Chest-percussion airway secretion-clearing system
Primary Device ID00816305023985
NIH Device Record Key065c9d32-d303-4b43-a636-9747f8059004
Commercial Distribution StatusIn Commercial Distribution
Brand NameAffloVest
Version Model Number8100XXS
Company DUNS146295980
Company NameTACTILE SYSTEMS TECHNOLOGY, INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816305023985 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-08

On-Brand Devices [AffloVest]

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

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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