FDA.reportPublic FDA data

Gastric Alimetry Array

Primary DI
09421906857016
Brand
Gastric Alimetry Array
Company
ALIMETRY LIMITED
Model
AS001-1
Device description
Gastric Alimetry Array
Published
2022-08-23
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421906857023PackageGS110In Commercial Distribution
09421906857108PackageGS15In Commercial Distribution
09421906857016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421906857023094219068570239421906857023
09421906857108094219068571089421906857108
09421906857016094219068570169421906857016

GMDN Terms#

Term, Definition table
TermDefinition
Myoelectric gastrointestinal motility analysis systemAn assembly of devices designed to non-invasively measure gastric myoelectrical activity to assist in the diagnosis and evaluation of gastrointestinal motility disorders (e.g., tachygastria, bradygastria, functional outlet obstruction). The assembly includes an electrically-powered control unit with attached noninvasive skin myoelectric sensor(s), connected to a computing device for analysis and display. Otherwise known as an electrogastrogram, it is typically intended as an alternative to invasive manometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+0016514477228Support@Alimetry.com

Regulatory Flags#

DUNS number
671514287
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421906857122Gastric Alimetry KitAK001-A2023-06-20
09421906857009Alimetry ReaderAL001-A2022-08-23
09421906857030Gastric Alimetry DockAD0012022-08-23
09421906857023Gastric AlimetryAS001-12022-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011391500GutTrackerG-TECH MEDICAL, INC.MYE2024-06-10
09421906857122Gastric Alimetry KitALIMETRY LIMITEDMYE2023-06-20
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