ZephyrLIFE Home 9607.0258

GUDID 10884521712980

ZL Home Kit - G

ZEPHYR TECHNOLOGY LLC

Electrocardiograph, professional, single-channel
Primary Device ID10884521712980
NIH Device Record Keyf7ddd9d7-004c-4ce7-a067-aa4cfbfe2c4b
Commercial Distribution Discontinuation2016-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZephyrLIFE Home
Version Model Number9607.0258
Catalog Number9607.0258
Company DUNS796678527
Company NameZEPHYR TECHNOLOGY LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521712980 [Primary]

FDA Product Code

DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-11-28
Device Publish Date2016-09-24

On-Brand Devices [ZephyrLIFE Home]

10884521712928ZL Home Kit - A
10884521712911ZL Home Kit - Demo
10884521713000ZL Home Kit - J
10884521712959ZL Home Kit - D
10884521712997ZL Home Kit - H
10884521712980ZL Home Kit - G
10884521712973ZL Home Kit - F
10884521712966ZL Home Kit - E
10884521712942ZL Home Kit - C
10884521712935ZL Home Kit - B
10884521712898ZephyrLIFE Home HealthHub Patient Software Application?

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.