AccessGUDID - DEVICE: 12 uPAT Probes for Watch-PAT200U (07290109222011)

GUDID

Device Identifier (DI) Information

Brand Name: 12 uPAT Probes for Watch-PAT200U
Version or Model: 12 uPAT Probes for Watch-PAT200U
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AC2101200
Company Name: ITAMAR MEDICAL LTD

Primary DI Number: 07290109222011
Issuing Agency: GS1
Commercial Distribution End Date: October 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 531857076 *Terms of Use

Device Description: 12 uPAT Probes

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:	Yes
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?
47686	Cardiovascular-risk peripheral arterial tonometry system sensor	An pneumo-electronic device, typically designed as a proximal annular cuff incorporating plethysmography-based pneumatic bio-sensor, that is placed on a patient's finger during a reactive hyperemia test for the assessment of endothelial dysfunction (poor vasodilatory response) and arterial stiffness. It is connected to the cardiovascular-risk peripheral arterial tonometry system data processor and imparts a uniform pressure field to the distal two thirds of the finger, including the tip, to measure arterial pulsatile volume changes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNR	Ventilatory Effort Recorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133859	000
K153070	000
K161579	000
K180775	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
Handling Environment Atmospheric Pressure: between 68.947 and 103.42 KiloPascal
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 68.947 and 103.42 KiloPascal
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05949858-3618-47d7-8754-4fe59292c4a3
Public Version Date: October 17, 2023
Public Version Number: 4
DI Record Publish Date: September 05, 2016