Travanti

Primary DI
20815611021016
Brand
Travanti
Company
LTS Therapy Systems, LLC
Model
80
Device description
This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 10815611020012 2) Saline: Primary DI Number, 04026704396047 The 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
Rx
false
OTC
false
Sterile
false
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
20815611021016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081561102101620815611021016

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.

Contacts#

Phone, Email table
PhoneEmail
651-552-5622steve.leno@ltslohmann.com

Regulatory Flags#

DUNS number
006154595
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
20815611021023TravantiSP2016-10-03
20815611021030TravantiExtra Strength2016-10-03