AccessGUDID - DEVICE: Midmark IQholter Digital Holter (00841709100598)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark IQholter Digital Holter
Version or Model: 4-000-0110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4-000-0110
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709100598
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: The Midmark IQholter system combines a compact digital recorder with three powerful software applications. Easy-to-use Holter software with fully automated analysis and reporting, designed for routine monitoring situations in fast-paced offices. Kit includes: Midmark IQholter Recorder (includes lead wire set, secure digital card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key USB Version, and Holter Prep Kits.

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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36827	Electrocardiographic long-term ambulatory recording analyser	An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.	Active	false

FDA Product Code

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Product Code	Product Code Name
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 3.7" x 2.6" x 1.06"; Weight: 2.8 oz. (no battery or SD card)

Device Record Status

Public Device Record Key: 98123a1f-0466-498f-8beb-93024466d3d2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016