FDA.reportPublic FDA data

Brio™

Primary DI
05414734405591
Brand
Brio™
Company
ST. JUDE MEDICAL, INC.
Model
6722
Catalog number
6722
Device description
LE Charging System
Published
2025-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHYStimulator, electrical, implanted, for parkinsonian tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734405591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734405591054147344055915414734405591

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199150017850N/AMEDTRONIC, INC.MHY2026-02-05
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729989240Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
00643169955653N'VISION®MEDTRONIC, INC.MHY2024-10-04
00763000523312N/AMEDTRONIC, INC.MHY2024-01-19
00191506014339Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2023-10-02
00191506014346Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2023-10-02
00191506023577NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2022-10-31
00191506023584NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2022-10-31
00763000404413N/AMEDTRONIC, INC.MHY2022-05-02
00763000274320DBS™MEDTRONIC, INC.MHY2021-12-16
00763000274399DBS™MEDTRONIC, INC.MHY2021-12-16
00763000274405DBS™MEDTRONIC, INC.MHY2021-12-16
00763000519216Percept™ PC BrainSense™MEDTRONIC, INC.MHY2021-10-17
00763000519223Activa® SCMEDTRONIC, INC.MHY2021-10-17
00763000519230Activa® SCMEDTRONIC, INC.MHY2021-10-17
00763000411916N/AMEDTRONIC, INC.MHY2021-07-30
08714729985037Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-06-25
08714729985051Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-06-25
00763000426378SenSight™MEDTRONIC, INC.MHY2021-06-05