GutTracker

Primary DI
00860011391500
Brand
GutTracker
Company
G-TECH MEDICAL, INC.
Model
Gen 2
Catalog number
1001
Device description
GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYESystem, Electrogastrography (Egg)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYESystem, Electrogastrography (Egg)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212954000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212954000G-Tech Wireless Patch System (WPS)G-Tech Medical2022-01-10MYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011391517PackageGS13In Commercial Distribution
00860011391500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011391517008600113915178600113915170860011391517
00860011391500008600113915008600113915000860011391500

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple vital physiological parameter monitoring systemA portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.3Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-282-4776info@gtechmedical.com

Regulatory Flags#

DUNS number
053029908
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09421906857122Gastric Alimetry KitALIMETRY LIMITEDMYE2023-06-20
09421906857016Gastric Alimetry ArrayALIMETRY LIMITEDMYE2022-08-23
09421906857009Alimetry ReaderALIMETRY LIMITEDMYE2022-08-23
09421906857023Gastric AlimetryALIMETRY LIMITEDMYE2022-08-23
09421906857030Gastric Alimetry DockALIMETRY LIMITEDMYE2022-08-23
008643590002303CPM Company, Inc.3CPM CO., INC.MYE2020-08-18
008643590002473CPM Company, Inc.3CPM CO., INC.MYE2020-08-18
008643590002543CPM Company, Inc.3CPM CO., INC.MYE2020-08-18
008643590002613CPM Company, Inc.3CPM CO., INC.MYE2020-08-18
008643590002783CPM Company, Inc.3CPM CO., INC.MYE2020-08-18
008643590002853CPM Company, Inc.3CPM CO., INC.MYE2020-08-18
008643590002923CPM Company, Inc.3CPM CO., INC.MYE2020-08-18
008643590002093CPM Company, Inc3CPM CO., INC.MYE2016-09-27
008643590002163CPM Company, Inc3CPM CO., INC.MYE2016-09-27
008643590002233CPM Company, Inc3CPM CO., INC.MYE2016-09-27
07290101363330Polygraf IDGiven Imaging, Inc.MYE2016-09-24