DEVICE: Renamic PGH (04035479114510)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRG | Programmer, pacemaker |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P950037 | 089 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit |
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between 0 and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e8468a9c-6ce0-4042-940c-3cf5cdc88871
July 06, 2018
3
August 21, 2014
July 06, 2018
3
August 21, 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 |
---|---|
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(888)345-0374
jon.brumbaugh@biotronik.com
jon.brumbaugh@biotronik.com