DEVICE: Medtronic CareLink® Programmer (00613994434937)
Device Identifier (DI) Information
Medtronic CareLink® Programmer
2090
Not in Commercial Distribution
MEDTRONIC, INC.
2090
Not in Commercial Distribution
MEDTRONIC, INC.
PROG 2090 TELC USA MKT EN EXT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -7.6 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
075c0d3d-af38-4b4c-8548-e31b0217a5e5
July 06, 2018
4
September 23, 2014
July 06, 2018
4
September 23, 2014
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 |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com