FDA.reportPublic FDA data

InTouch Health

Primary DI
00868772000143
Brand
InTouch Health
Company
INTOUCH TECHNOLOGIES, INC.
Model
Lite Remote Presence System V3
Catalog number
20-13333
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120895000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120895000REMOTE PRESENCE SYSTEMIntouch Health, Inc.2012-05-24DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868772000143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868772000143008687720001438687720001430868772000143

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic imaging telemedicine systemAn assembly of devices designed to electronically transmit digitized radiology images, e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine, ultrasound, endosocopy or CT, and consultative text to one or more remote sites (teleradiology). The information is typically transmitted through, e.g., public service transmission channels, phone lines or microwave relays. It is primarily distinguished from a picture archiving and communication system (PACS) by its storage capacity and intended use. PACS is a large storage system and file controller storing and retrieving thousands of images, whilst a teleradiology system typically has a storage capacity of fewer than 1, 000 images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
133033717
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868772000174InTouch HealthInTouch Imaging2019-03-19
00860000825818InTouch HealthInTouch Lite 4 with Boom2019-03-19
00868772000181InTouch HealthInTouch Lite 42019-03-19
00868772000105InTouch HealthVita Remote Presence System20-159732016-09-22
00868772000112InTouch HealthVantage Remote Presence System2016-09-22
00868772000136InTouch HealthXpress Remote Presence System Version 220-143932016-12-09
00868772000150InTouch HealthLite Remote Presence System V22016-09-22

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Primary DI, Brand, Company table
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