AccessGUDID - DEVICE: CARELINK® MONITOR (00643169102101)

GUDID

Device Identifier (DI) Information

Brand Name: CARELINK® MONITOR
Version or Model: 2490H9
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169102101
Issuing Agency: GS1
Commercial Distribution End Date: January 25, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: MON 2490H9 CARELINK EXPRESS USA RFB

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?
61438	Cardiac pulse generator reader, home-use	An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. 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. This is a home-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NVZ	Pulse generator, permanent, implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890003	110

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 Temperature: between -40 and 150 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea2bd91e-00df-4040-bef8-6328b8604629
Public Version Date: February 18, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2014