AccessGUDID - DEVICE: Ontrak (10841522129582)

GUDID

Device Identifier (DI) Information

Brand Name: Ontrak
Version or Model: ABP Cuffs and Cuff Covers
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 015-0067-06Q
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522129582
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX

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?
36888	Blood pressure ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, measurement, blood-pressure, non-invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141113	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 17-26 cm OD
Device Size Text, specify: 7-10 in. OD

Device Record Status

Public Device Record Key: 27dc45f6-2274-4fd1-85bd-ef83c585b7e4
Public Version Date: July 04, 2024
Public Version Number: 2
DI Record Publish Date: June 07, 2024