FDA.reportPublic FDA data

NA

Primary DI
00851920007194
Brand
NA
Company
ZOE MEDICAL INCORPORATED
Model
ECG Intermediate Cable
Catalog number
01-02-0920
Device description
ECG Intermediate Cable, 3-lead, 2 meter, AAMI
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150620000740 SELECTCas Medical Systems, Inc.2015-05-08MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851920007194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851920007194008519200071948519200071940851920007194

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
978-887-4013customersupport@zoemedical.com

Regulatory Flags#

DUNS number
848429929
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851920007170NAECG Lead, 3 meter421-00462016-09-22
00851920007200NAECG Lead, 1 meter01-02-09272016-09-22
00851920007217NAECG Lead, 1 meter01-02-09232016-09-22
00851920007224NAECG Lead, 1 meter01-02-09222016-09-22
00851920007255NAECG Lead, 1 meter01-02-09222017-01-28
00851920007262NAECG Lead, 1 meter01-02-09252017-01-31
00851920007446740 SELECT740 SELECT-0N0E001-02-10252022-09-27
00851920007408740 SELECT740 SELECT-XMF0W01-02-10332020-08-12
00851920007415740 SELECT740 SELECT-XM0EW01-02-10482020-08-12
00851920007422740 SELECT740 SELECT-XN0EW01-02-10492020-08-12
00851920007392740 SELECT740 SELECT-XNFE001-02-10212020-05-04
00851920007309DM491331-N91331-N2019-06-01
00851920007316DM491331-NF91331-NF2019-06-01
00851920007323DM491331-NW91331-NW2019-06-01
00851920007330DM491331-NFW91331-NFW2019-06-01
00851920007385740 SELECT740 SELECT-0NF0001-02-10142019-08-27
00851920007347DM491331-M91331-M2019-06-15
00851920007354DM491331-MF91331-MF2019-06-15
00851920007361DM491331-MW91331-MW2019-06-15
00851920007378DM491331-MFW91331-MFW2019-06-15

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