FDA.reportPublic FDA data

PATIENT CABLE - 3 LEAD DN

Primary DI
00841034112198
Brand
PATIENT CABLE - 3 LEAD DN
Company
RPI
Model
KCA016
Catalog number
KCA016
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942321000VARIOUSPATIENT MONITORING CABLEMerit Cables Incorporated1994-11-04DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841034112198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841034112198008410341121988410341121980841034112198

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA 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 (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
818-882-8611techsupport@rpiparts.com

Regulatory Flags#

DUNS number
066232067
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841034110798ACQUISITION MODULE CABLEGEC020GEC0202016-12-09
00841034110804ACQUISITION MODULE CABLEGEC021GEC0212016-12-09
00841034112136TELEMETRY CABLE 2 LEAD SNKBB001KBB0012016-12-09
00841034112143PATIENT CABLE - 3 LEAD DNKCA001KCA0012016-12-09
00841034112150PATIENT CABLE - 3 LEAD DNKCA004KCA0042016-12-09
00841034112167PATIENT CABLE - 3 LEAD DNKCA007KCA0072016-12-09
00841034112174PATIENT CABLE - 3 LEAD DNKCA010KCA0102016-12-09
00841034112181PATIENT CABLE - 3 LEAD DNKCA013KCA0132016-12-09
00841034112204PATIENT CABLE - 3 LEAD DNKCA019KCA0192016-12-09
00841034112211PATIENT CABLE - 3 LEAD DNKCA022KCA0222016-12-09
00841034112228PATIENT CABLE - 3 LEAD DNKCA025KCA0252016-12-09
00841034112235PATIENT CABLE - 3 LEAD DNKCA035KCA0352016-12-09
00841034112242PATIENT CABLE - 3 LD FX SNKCB002KCB0022016-12-09
00841034112259PATIENT CABLE - 3 LD FX SNKCB008KCB0082016-12-09
00841034112266TELEMETRY CABLE 3 LEAD SNKCB028KCB0282016-12-09
00841034112273TELEMETRY CABLE 3 LEAD SNKCB029KCB0292016-12-09
00841034112280TELEMETRY CABLE 3 LEAD SNKCB031KCB0312016-12-09
00841034112297TELEMETRY CABLE 3 LEAD PIKCB032KCB0322016-12-09
00841034112303PATIENT CABLE - 3 LD FX SNKCB036KCB0362016-12-09
00841034112310PATIENT CABLE - 3 LEAD DUKCC003KCC0032016-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
00840416607406FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607413FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607420FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607437FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
00840416607444FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-19
G662ME590221F1MaguireMaguire Enterprises, Inc.DSA2026-10-19
G662ME590303G1MaguireMaguire Enterprises, Inc.DSA2026-10-16
00195278840202MACGe Medical Systems Information Technologies, Inc.DSA2026-10-13
06946725572139APKAPK Technology Co.,Ltd.DSA2026-10-13
042504134004853-channel ECG ElectrodeSOMNOmedics AGDSA2026-10-09
G662ME3311MaguireMaguire Enterprises, Inc.DSA2026-10-09
G662ME3381MaguireMaguire Enterprises, Inc.DSA2026-10-09
00840416607345FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607352FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607369FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607376FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607383FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
00840416607390FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-10-05
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
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