FDA.reportPublic FDA data

Gastric Alimetry

Primary DI
09421906857023
Brand
Gastric Alimetry
Company
ALIMETRY LIMITED
Model
AS001-1
Device description
Gastric Alimetry Array
Published
2022-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
K213924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213924000Gastric Alimetry SystemAlimetry , Ltd.2022-06-03MYE

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
671514287
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
09421906857016Gastric Alimetry ArrayAS001-12022-08-23
09421906857122Gastric Alimetry KitAK001-A2023-06-20
09421906857009Alimetry ReaderAL001-A2022-08-23
09421906857030Gastric Alimetry DockAD0012022-08-23

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
09421906857016Gastric Alimetry ArrayALIMETRY LIMITEDMYE2022-08-23
09421906857009Alimetry ReaderALIMETRY 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