AccessGUDID - DEVICE: Accessories, EndoPATx (07290109225227)

GUDID

Device Identifier (DI) Information

Brand Name: Accessories, EndoPATx
Version or Model: Accessories, EndoPATx
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AC0001650
Company Name: ITAMAR MEDICAL LTD

Primary DI Number: 07290109225227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531857076 *Terms of Use

Device Description: Accessories for EndoPATx

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:	No
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?
47687	Cardiovascular-risk peripheral arterial tonometry system	An electrically-powered assembly of devices designed to assess peripheral artery endothelial dysfunction (poor vasodilatory response) and/or arterial stiffness through the noninvasive measurement of arterial pulsatile volume changes in the fingertip during a reactive hyperemia test (occlusion of blood flow followed by abrupt release). It typically includes a dedicated bio-sensor applied to a finger or arm and a computer/software-controlled device used to process, store, display, and help analyse peripheral arterial tone (PAT) data received from the sensor. Endothelial dysfunction is a recognized marker of sub-clinical arteriosclerosis which is used as a predictor of cardiovascular events.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, Diagnostic, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211557	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 22 and 24 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2f79eccc-8454-44fd-8191-509bdb78d6bd
Public Version Date: May 05, 2023
Public Version Number: 1
DI Record Publish Date: April 27, 2023