FDA.report

Rapid Programmer™

Primary DI
05415067018014
Brand
Rapid Programmer™
Company
ST. JUDE MEDICAL, INC.
Model
3834
Catalog number
3834
Published
2015-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Product Code Classifications

CodeDeviceSpecialtyClass
LGWStimulator, Spinal-Cord, Totally Implanted For Pain ReliefUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05415067018014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05415067018014054150670180145415067018014

GMDN Terms

TermDefinition
Multiple active implantable device programmerAn external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal101 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal101 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04035479188733Neuro PR app 2400.UBIOTRONIK SE & Co. KGLGW2025-03-27
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00763000586850N/AMEDTRONIC, INC.LGW2024-05-06
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00763000287306N/AMEDTRONIC, INC.LGW2024-05-05
00763000371463N/AMEDTRONIC, INC.LGW2024-05-05
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