FDA.reportPublic FDA data

Zephyr

Primary DI
10884521706026
Brand
Zephyr
Company
ZEPHYR TECHNOLOGY LLC
Model
BIOMODULE HOLDER
Catalog number
BIOMODULE HOLDER
Device description
BIOMODULE HOLDER
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521713574PackageGS199Not in Commercial Distribution
10884521706026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452171357410884521713574
1088452170602610884521706026

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
796678527
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521712898ZephyrLIFE HomeSoftware HomeSoftware Home2016-09-24
10884521704817ZephyrBH3-M1BH3-M12016-10-13
10884521712904ZephyrLIFE HospitalSoftware HospitalSoftware Hospital2016-09-24
10884521725461ZephyrBH3-M2BH3-M22018-01-24
10884521712935ZephyrLIFE Home9607.02429607.02422016-09-24
10884521712942ZephyrLIFE Home9607.02439607.02432016-09-24
10884521712966ZephyrLIFE Home9607.02459607.02452016-09-24
10884521712973ZephyrLIFE Home9607.02469607.02462016-09-24
10884521712980ZephyrLIFE Home9607.02589607.02582016-09-24
10884521712997ZephyrLIFE Home9607.02579607.02572016-09-24
10884521712959ZephyrLIFE Home9607.02449607.02442016-09-24
10884521713000ZephyrLIFE Home9607.02599607.02592016-09-24
10884521712911ZephyrLIFE Home9607.02399607.02392016-09-24
10884521712928ZephyrLIFE Home9607.02412016-09-24
90884521725467ZephyrBH3-M2BH3-M22018-01-24
10884521758964Zephyr9607-02189607-02182018-01-24
10884521758995Zephyr9607-02159607-02152018-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
08033003267424NAFIAB SPADRX2021-03-31
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08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283093Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20