AccessGUDID - DEVICE: Remote Assistant (04035479158330)

GUDID

Device Identifier (DI) Information

Brand Name: Remote Assistant
Version or Model: III
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 435292
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479158330
Issuing Agency: GS1
Commercial Distribution End Date:
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?
47805	Implantable cardiac monitor programmer/transmitter/alarm	A hand-held, electrically-powered device designed to be operated by a clinician or patient to non-invasively change the settings (e.g., turn on/off) of an implantable cardiac monitor (ICM), and/or extract data from the implant, and/or provide an alarm function; it is not intended to communicate with a therapeutic cardiac implant. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. It may be used in the home or healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXD	RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190548	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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 14 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1e74199c-1dde-483c-ab2d-80cd66094cea
Public Version Date: January 09, 2020
Public Version Number: 2
DI Record Publish Date: July 10, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)345-0374
Email: jon.brumbaugh@biotronik.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES