Travanti

Primary DI
20815611021023
Brand
Travanti
Company
LTS Therapy Systems, LLC
Model
SP
Device description
This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200292) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992708000IONTOPATCHBirch Point Medical, Inc.2000-02-01EGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815611021023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081561102102320815611021023

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis patchA non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive, intended to be used as an alternative to injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866467-2824arnoldr@travantimedical.com
612-245-7088mezzettj@tapemark.com

Regulatory Flags#

DUNS number
006154595
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815611020005IontoPatchSTAT2016-10-03
10815611020012IontoPatch802016-10-03
10815611020029IontoPatchSP2016-10-03
10815611020036IontoPatchExtra Strength2016-10-03
20815611021009TravantiSTAT2016-10-03
20815611021016Travanti802016-10-03
20815611021030TravantiExtra Strength2016-10-03