AccessGUDID - DEVICE: Holter Analysis Software Apnea (M582NEMK1270)

GUDID

Device Identifier (DI) Information

Brand Name: Holter Analysis Software Apnea
Version or Model: Holter Analysis Software Apnea
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M582NEMK127
Company Name: Northeast Monitoring, Inc.

Primary DI Number: M582NEMK1270
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837441815 *Terms of Use

Device Description: Holter Analysis Software Apnea

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?
43239	Cardiac arrhythmia monitoring system	An assembly of devices comprised of modules or components (e.g., monitors, recorders, amplifiers) intended to be used to continually detect, measure, and display the electrical activity of the heart and to produce a visible or audible signal/alarm when an atrial or ventricular arrhythmia, such as a premature contraction or ventricular fibrillation, exists.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNR	Ventilatory Effort Recorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081861	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
No Device Sizes

Device Record Status

Public Device Record Key: 943319d6-2966-4bc5-a8c0-b443cc161987
Public Version Date: November 04, 2021
Public Version Number: 1
DI Record Publish Date: October 27, 2021