AccessGUDID - DEVICE: Home Monitoring Service Center (04035479144258)

GUDID

Device Identifier (DI) Information

Brand Name: Home Monitoring Service Center
Version or Model: 3.29
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 405553
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479144258
Issuing Agency: GS1
Commercial Distribution End Date: October 16, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315620229 *Terms of Use

Device Description: No description.

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?
38473	Patient health record information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSR	Pacemaker/icd/crt non-implanted components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950037	121

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: f9d4aef3-4b16-41a6-98e3-28c900fcc889
Public Version Date: October 19, 2020
Public Version Number: 4
DI Record Publish Date: December 03, 2014