FDA.reportPublic FDA data

ZephyrLIFE Home

Primary DI
10884521712973
Brand
ZephyrLIFE Home
Company
ZEPHYR TECHNOLOGY LLC
Model
9607.0246
Catalog number
9607.0246
Device description
ZL Home Kit - F
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521712973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452171297310884521712973

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796678527
Device count
1
Premarket exempt
true
Kit
true
Serial number
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
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
10884521706026ZephyrBIOMODULE HOLDERBIOMODULE HOLDER2016-09-24

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