FDA.reportPublic FDA data

9Line

Primary DI
G096PS5VPS0500
Brand
9Line
Company
Rising Eagle Medical LLC
Model
PS-5VPS-050
Catalog number
PS-5VPS-050
Device description
5V Leads, Pinch, SPU Shielded ECG Leadwires, 50in, Philips/Spacelabs Comp, AAMI, 50/BX
Published
2024-09-17
Public version status
New
Distribution status
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
G096PS5VPS0505PackageHIBCC50In Commercial Distribution
G096PS5VPS0500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, single-useA collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array to assist electrode placement. This is a single-use device.

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
00816396022553ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022560ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022577ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022706ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022713ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022812ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022829ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022836ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022843ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022850ECG Lead WiresIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00816396022911ECG Trunk CableIVY BIOMEDICAL SYSTEMS, INC.DSA2023-06-08
00840067102206Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-29
00840067102176Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00840067102183Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2018-11-28
00009336008254VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2018-09-28
00840067102497Cadwell Patch Electrode with Snap ConnectorCADWELL INDUSTRIES, INC.DSA2017-12-22
00816396022294ECG Patient CableIVY BIOMEDICAL SYSTEMS, INC.DSA2017-08-31
20884521148342KendallCardinal Health, Inc.DSA2017-08-02
00817266020778Patient Lead Wire Adapter SetMERIT CABLES INCORPORATEDDSA2017-05-09
00009336008216VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008223VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008230VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008247VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008261VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008278VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008315VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008322VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00009336008339VermedGRAPHIC CONTROLS ACQUISITION CORPDSA2017-02-28
00841034110798ACQUISITION MODULE CABLERPIDSA2016-12-09
00841034110804ACQUISITION MODULE CABLERPIDSA2016-12-09