SJM™

Primary DI
05414734502375
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
FL-1056
Catalog number
FL-1056
Device description
FLUSHING TOOL
Published
2016-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIKDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734502375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734502375054147345023755414734502375

GMDN Terms#

Term, Definition table
TermDefinition
Pacing lead implantation adaptorA small, sterile device intended to be connected to the proximal end of a compatible cardiac pacing lead containing a lumen for over-guidewire implantation, to enable flushing of the lumen (typically with heparinized saline) and aid insertion of a guidewire during implantation. The distal end of the device is intended to connect to the pacing lead; the proximal end is intended to act as both a Luer connector, for attachment of a syringe, and a wire guide for guidewire insertion; it is not intended to be implanted. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Handling Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit
Special Storage Condition, Specify00Do not use if package is damaged.
Storage Environment Temperature-5 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature23 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05414734509138NAST. JUDE MEDICAL, INC.NIK2026-03-04
05414734506380NAST. JUDE MEDICAL, INC.NIK2025-12-22
05415067050045Neutrino™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.NIK2025-02-11
05415067049513Entrant™ST. JUDE MEDICAL, INC.NIK2024-04-25
05415067049520Gallant™ST. JUDE MEDICAL, INC.NIK2024-04-25
00802526589744RESONATE™ HF CRT-DBOSTON SCIENTIFIC CORPORATIONNIK2021-07-12
05415067032829myMerlinPulse™ST. JUDE MEDICAL, INC.NIK2021-01-07
00763000178093Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178109Cobalt™ XT HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178130Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
00763000178147Cobalt™ XT HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-11-22
04035479140144Itrevia 5 HF-T QPBIOTRONIK SE & Co. KGNIK2020-10-07
00763000059996Compia MRI™ Quad CRT-D SureScan™MEDTRONIC, INC.NIK2020-09-04
00763000060091Compia MRI™ CRT-D SureScan™MEDTRONIC, INC.NIK2020-09-04
05415067032010Gallant™ST. JUDE MEDICAL, INC.NIK2020-09-02
05415067032850Entrant™ST. JUDE MEDICAL, INC.NIK2020-09-02
00763000178178Cobalt™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178185Cobalt™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178215Cobalt™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178222Cobalt™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178253Crome™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178260Crome™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178291Crome™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00763000178307Crome™ HF CRT-D MRI SureScan™MEDTRONIC, INC.NIK2020-06-08
00643169720732Compia MRI™ CRT-D SureScan™MEDTRONIC, INC.NIK2019-10-14
04035479156725Ilivia Neo 7 HF-T QPBIOTRONIK SE & Co. KGNIK2019-09-10
04035479156732Ilivia Neo 7 HF-TBIOTRONIK SE & Co. KGNIK2019-09-10
04035479156824Intica Neo 7 HF-T QPBIOTRONIK SE & Co. KGNIK2019-09-10