AccessGUDID - DEVICE: 12 Pneumatic Endo probes for Endo PAT 2000 (07290109225005)

GUDID

Device Identifier (DI) Information

Brand Name: 12 Pneumatic Endo probes for Endo PAT 2000
Version or Model: 12 Pneumatic Endo probes for Endo PAT 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AC1600005
Company Name: ITAMAR MEDICAL LTD

Primary DI Number: 07290109225005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531857076 *Terms of Use

Device Description: 12 Pneumatic Endo 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
DQK	Computer, Diagnostic, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032519	000
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
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Temperature: between 22 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2630e40-d13d-4c1e-9445-f4a1562a7944
Public Version Date: June 14, 2023
Public Version Number: 4
DI Record Publish Date: September 05, 2016