FDA.reportPublic FDA data

SJM™

Primary DI
05414734405362
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
2004
Catalog number
2004
Published
2015-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
GZFSTIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130545000MULTI LEAD TRIAL CABLESt Jude Medical2013-06-18GZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734405362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734405362054147344053625414734405362

GMDN Terms#

Term, Definition table
TermDefinition
Pin-indexed adaptor, reusableA connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Handling Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067032195EnSite™ENSITE-FF-01ENSITE-FF-012021-01-06
05415067032201EnSite™ENSITE-R-FF-01ENSITE-R-FF-012021-01-06
05415067024732EnSite Precision™H702473H7024732020-07-22
05415067024695EnSite Precision™H702469H7024692016-12-20
05415067024701EnSite Precision™H702470H7024702016-12-20
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
05415067054661TactiSys™TSQ-V1.8-TFDM-01TSQ-V1.8-TFDM-012026-08-19
05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537035932Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-19
00812537035932Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-19
00812537036915Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-17
00812537036915Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-17
00812537030272Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537030272Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537030296Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537030296Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537030883Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537030883Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537036953Nalu Medical, Inc.NALU MEDICAL, INC.GZF2026-08-07
00812537036953Nalu Medical, Inc.NALU MEDICAL, INC.GZB2026-08-07
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZF2026-02-26
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZB2026-02-26
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032917Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537030630Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537031910Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537032986Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030098Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21