FDA.reportPublic FDA data

ZephyrLIFE Hospital

Primary DI
10884521712904
Brand
ZephyrLIFE Hospital
Company
ZEPHYR TECHNOLOGY LLC
Model
Software Hospital
Catalog number
Software Hospital
Device description
ZephyrLIFE Hospital Application Software Application?
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
10884521712904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452171290410884521712904

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521712898ZephyrLIFE HomeSoftware HomeSoftware Home2016-09-24
10884521704817ZephyrBH3-M1BH3-M12016-10-13
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
10884521706026ZephyrBIOMODULE HOLDERBIOMODULE HOLDER2016-09-24

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