FDA.reportPublic FDA data

STREAMLINE™

Primary DI
00613994365422
Brand
STREAMLINE™
Company
MEDTRONIC, INC.
Model
6494F
Device description
WIRE 6494F TEMP PACE UNI 12PK of 2 20L
Published
2015-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012459000MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIREMedtronic Vascular2001-08-14LDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994365426PackageGS112In Commercial Distribution
00613994365422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399436542620613994365426
00613994365422006139943654226139943654220613994365422

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker, epicardial pacingAn external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507166Bipolar Pacing CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.LDF2026-05-04
10801902216110ARROWTELEFLEX INCORPORATEDLDF2023-07-14
10801902198386ARROWTELEFLEX INCORPORATEDLDF2022-11-18
08718627412701MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2016-04-25
08718627411674MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411698MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411711MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411735MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411759MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411773MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411797MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411810MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411834MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411858MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411872MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411896MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411919MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411933MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411957MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411971MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411995MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412015MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412039MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412053MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412077MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412091MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412114MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412138MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412152MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412176MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11