FDA.reportPublic FDA data

9Line

Primary DI
G0963SS0300
Brand
9Line
Company
Rising Eagle Medical LLC
Model
3SS-030
Catalog number
3SS-030
Device description
3 Lead, Snap, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
Published
2022-02-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0963SS0305PackageHIBCC50In Commercial Distribution
G0963SS0300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of non-sterile, noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-399-0119info@rem-supplies.com

Regulatory Flags#

DUNS number
080145608
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0960R867530909LineR-8675309R-86753092024-01-30
G096MNK3NT100MEDALinkM-NK-3NT-10M-NK-3NT-102025-10-08
G096MNKS2NKT100MEDALinkM-NK-S2NKT-10M-NK-S2NKT-102025-10-08
G096MNKS2NORAC30MEDALinkM-NK-S2NOR-AC-3M-NK-S2NOR-AC-32025-10-08
G096MNKS2NOT100MEDALinkM-NK-S2NOT-10M-NK-S2NOT-102025-10-08
G096MPHS2E0840MEDALinkM-PH-S2E-084M-PH-S2E-0842025-10-08
G096MPHS2T0420MEDALinkM-PH-S2T-042M-PH-S2T-0422025-10-08
G096MPHS2T0840MEDALinkM-PH-S2T-084M-PH-S2T-0842025-10-08
G096MPHS2T1200MEDALinkM-PH-S2T-120M-PH-S2T-1202025-10-08
G096MMR5PS0500MEDALinkM-MR-5PS-050M-MR-5PS-0502024-07-27
G096PS3SS05009LinePS-3SS-050PS-3SS-0502024-09-17
G096MDR5TMP100MEDALinkM-DR-5TMP-10M-DR-5TMP-102024-09-15
G096MGEPH10T150MEDALinkM-GE-PH510T-15M-GE-PH510T-152024-07-29
G096MA0816C030030MEDALinkM-A0816-C03-003M-A0816-C03-0032023-03-22
G096MA0816C030040MEDALinkM-A0816-C03-004M-A0816-C03-0042023-03-22
G096MA5085EK2PH0010MEDALinkM-A5085-EK2PH-001M-A5085-EK2PH-0012023-03-22
G096MGE5GEE100MEDALinkM-GE-5GE-E-10M-GE-5GE-E-102025-02-18
G096MGE5GEE150MEDALinkM-GE-5GE-E-15M-GE-5GE-E-152025-02-18
G096MMX40120MEDALinkM-MX40-12M-MX40-122023-04-22
G0963PS03009Line3PS-0303PS-0302022-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607185FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME3641MaguireMaguire Enterprises, Inc.DSA2026-07-31
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280M1MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280T11MaguireMaguire Enterprises, Inc.DSA2026-07-28
G662ME590280Y1MaguireMaguire Enterprises, Inc.DSA2026-07-28
03700506300853INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-07-24