FDA.reportPublic FDA data

AtriAmp - Pacing Cable

Primary DI
00860004773719
Brand
AtriAmp - Pacing Cable
Company
Atrility Medical LLC
Model
10039
Device description
Pacing Cable, 6FT, Medtronic® Connector
Published
2021-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200674000AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor ConnectorAtrility Medical, LLC2020-07-02DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860004773716PackageGS15In Commercial Distribution
20860004773713PackageGS16In Commercial Distribution
00860004773719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000477371610860004773716
2086000477371320860004773713
00860004773719008600047737198600047737190860004773719

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
080558780
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004773733AtriAmp - Pacing Cable10039-122026-08-18
00860004773702AtriAmp100012021-01-01
10860004773709AtriAmp100012021-01-01
10860004773716AtriAmp - Pacing Cable100392021-01-01
00860004773726AtriAmp - Pacing Cable100522021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572108APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572115APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572122APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725571712APKAPK Technology Co.,Ltd.IKD2026-07-01
06946725500866APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500873APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500880APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500897APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500903APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500910APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500927APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500934APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500941APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500958APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500965APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500972APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22