AccessGUDID - DEVICE: Midmark IQholter® Digital Holter Recorder Kit (00841709100628)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark IQholter® Digital Holter Recorder Kit
Version or Model: 4-000-0119
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4-000-0119
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709100628
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQHolter Recorder, Lead wire set, Secure Digital Card, Four Holter Prep Kits, and Reusable IQholter Recorder Pouch and Belt.

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:	Yes
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?
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

[?]

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: 0ae7bf8b-1bab-4150-bf0c-928383333a10
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016