FDA.reportPublic FDA data

3CPM Company, Inc.

Primary DI
00864359000254
Brand
3CPM Company, Inc.
Company
3CPM CO., INC.
Model
1
Device description
Respiratory Belt for 3CPM Electrogastrography system
Published
2020-08-18
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
00864359000254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864359000254008643590002548643590002540864359000254

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

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
008643590002613CPM Company, Inc.12020-08-18
008643590002783CPM Company, Inc.12020-08-18
008643590002853CPM Company, Inc.2.09g2020-08-18
008643590002093CPM Company, Inc2.09e2016-09-27
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
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