AccessGUDID - DEVICE: CareLink Encore™ (00643169369030)

GUDID

Device Identifier (DI) Information

Brand Name: CareLink Encore™
Version or Model: 29901
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169369030
Issuing Agency: GS1
Commercial Distribution End Date: February 25, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: PROGRAMMER 29901 CARELINK ENCORE US

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?
47205	Cardiac pulse generator programmer	An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXY	implantable pacemaker Pulse-generator
OSR	Pacemaker/icd/crt non-implanted components
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
KRG	Programmer, pacemaker
NVZ	Pulse generator, permanent, implantable
LWP	Implantable pulse generator, pacemaker (non-CRT)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890003	254
P890003	371

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 -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00fe881e-fc7a-4dc7-b0ee-1e29539b62ea
Public Version Date: July 31, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2014