FDA.reportPublic FDA data

Vermed

Primary DI
10009336008947
Brand
Vermed
Company
GRAPHIC CONTROLS ACQUISITION CORP
Model
Trunk Cable GE Case-MAC 5000-CAM14
Catalog number
32028946
Device description
IP Set Adapter Cable
Published
2018-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101685000IP-SETIntegral Process Sas2010-07-01DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10009336008947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1000933600894710009336008947

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electrocardiographicA small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.

Contacts#

Phone, Email table
PhoneEmail
800-669-6905info@vermed.com

Regulatory Flags#

DUNS number
002111896
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10009336009425Hillrom1080711080712019-10-02
10009336009760Hillrom1080701080702019-10-01
00009336008216Vermed20100-125-SNAP20100-125-SNAP2017-02-28
00009336008223Vermed20300-18-RED20300-18-RED2017-02-28
00009336008230Vermed20300-18-WHT20300-18-WHT2017-02-28
00009336008247Vermed20900-18-3A20900-18-3A2017-02-28
00009336008254Vermed20900-24-3A20900-24-3A2018-09-28
00009336008261Vermed20900-53-GRN20900-53-GRN2017-02-28
00009336008278Vermed20900-96-RED20900-96-RED2017-02-28
00009336008315Vermed41656416562017-02-28
00009336008322Vermed20900-18-RED20900-18-RED2017-02-28
00009336008339Vermed20900-48-WHT20900-48-WHT2017-02-28
30009336010630Nissha Medical TechnologiesUltra 210HD Thermal Video Paper320190642026-06-01
10009336010322Zoll PL Defib8900-004041-017000018322023-10-30
10813150020227PerformancePlus™A10005A100052016-09-16
50813150020911NeuroPlus™A10041-5A10041-52017-04-07
00813150020107PerformancePlus™A10005-4NBA10005-4NB2016-09-16
00813150020121PerformancePlus™A10005-60A10005-602016-09-16
00813150020183PerformancePlus™A10005-7NBA10005-7NB2016-09-16
20813150020941NeuroPlus™A10042-10A10042-102017-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
G662ME590303G1MaguireMaguire Enterprises, Inc.DSA2026-10-16
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
06946725572139APKAPK Technology Co.,Ltd.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17