AccessGUDID - DEVICE: ZephyrLIFE Home (10884521712959)

GUDID

Device Identifier (DI) Information

Brand Name: ZephyrLIFE Home
Version or Model: 9607.0244
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9607.0244
Company Name: ZEPHYR TECHNOLOGY LLC

Primary DI Number: 10884521712959
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 796678527 *Terms of Use

Device Description: ZL Home Kit - D

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11413	Electrocardiograph, professional, single-channel	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5665828-c3ab-4681-a375-929f412fc969
Public Version Date: November 28, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016