FDA.reportPublic FDA data

9Line

Primary DI
G0963PS0305
Brand
9Line
Company
Rising Eagle Medical LLC
Model
3PS-030
Catalog number
3PS-030
Device description
3 Lead, Pinch, SPU Shielded ECG Leadwires, 30in, Philips Comp, AAMI, 50/BX
Published
2022-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
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
G0963PS0305PackageHIBCC50In Commercial Distribution
G0963PS0300PrimaryHIBCC0

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
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
G662ME590030R1MaguireMaguire Enterprises, Inc.DSA2026-07-14
04048675729631ECG trunk cable 12-lead SinglePin Vista300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
04048675729655Adapter cable Masimo/ Nellcor SpO2 Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
04048675746768Temp adapter Jack Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435398CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435404CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435411CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973439082CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457116CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457123CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457130CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457147CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457154CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457161CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457185CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457192CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457208CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457215CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457246CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
08720938410284QMAPPFysicon B.V.DSA2026-06-26
G662ME590030M31MaguireMaguire Enterprises, Inc.DSA2026-06-24
G662ME5921011MaguireMaguire Enterprises, Inc.DSA2026-06-10
00840416606898FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606904FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606911FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606928FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606935FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606942FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02
00840416606959FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-06-02