FDA.reportPublic FDA data

3CPM Company, Inc

Primary DI
00864359000209
Brand
3CPM Company, Inc
Company
3CPM CO., INC.
Model
2.09e
Device description
The 3CPM Company, Inc Electrogastrogram Waterload platform Unit. Device uses ECG-like technology to capture the electrical waves of the stomach and intestines.
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
DEN990005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN990005000THE 3PM EGG MACHINE3pm Co., Inc.1999-08-20MYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864359000209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864359000209008643590002098643590002090864359000209

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel) but may otherwise include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included. It is intended to be used by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022772521
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008643590002233CPM Company, Inc2.09e2016-09-27
008643590002303CPM Company, Inc.1.022020-08-18
008643590002473CPM Company, Inc.2.09g2020-08-18
008643590002543CPM Company, Inc.12020-08-18
008643590002613CPM Company, Inc.12020-08-18
008643590002783CPM Company, Inc.12020-08-18
008643590002853CPM Company, Inc.2.09g2020-08-18
008643590002163CPM Company, Inc2.09e2016-09-27
008643590002923CPM Company, Inc.2.09g2020-08-18

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
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
008643590002163CPM Company, Inc3CPM CO., INC.MYE2016-09-27
008643590002233CPM Company, Inc3CPM CO., INC.MYE2016-09-27
07290101363330Polygraf IDGiven Imaging, Inc.MYE2016-09-24