AccessGUDID - DEVICE: Medtronic CareLink® Programmer (00613994434937)

GUDID

Device Identifier (DI) Information

Brand Name: Medtronic CareLink® Programmer
Version or Model: 2090
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994434937
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: PROG 2090 TELC USA MKT EN EXT

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
KRG	Programmer, pacemaker
OSR	Pacemaker/icd/crt non-implanted components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P890003	145

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 -7.6 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 075c0d3d-af38-4b4c-8548-e31b0217a5e5
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2014