FDA.reportPublic FDA data

NA

Primary DI
00883873940488
Brand
NA
Company
PHYSIO-CONTROL, INC.
Model
11111
Catalog number
11111-000021
Device description
CBL, 4WIRE LIMB LEAD-8FTIEC, 12 LEAD ECG 3RD ED
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142430000LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.2014-12-19MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883873940488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883873940488008838739404888838739404880883873940488

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Feet

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Handling Environment Temperature-30 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-1142rs.seacustomersupport@physio-control.com
+1(800)442-1142rs.seacustomersupport@stryker.com

Regulatory Flags#

DUNS number
009251992
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883873031902LIFEPAK 35 Monitor/Defibrillator7033570335-0002242026-04-17
00883873031933LIFEPAK 35 Monitor/Defibrillator7033570335-0002262026-04-17
00883873031957LIFEPAK 35 Monitor/Defibrillator7033570335-0002272026-04-17
00883873031971LIFEPAK 35 Monitor/Defibrillator7033570335-0002282026-04-17
00883873031995LIFEPAK 35 Monitor/Defibrillator7033570335-0002292026-04-17
00883873032015LIFEPAK 35 Monitor/Defibrillator7033570335-0002302026-04-17
00883873032145LIFEPAK 35 Monitor/Defibrillator7033570335-0002312026-04-17
00883873834374CABLE, PRINTER, LP351133011330-0000142024-06-19
07613327673197LIFEPAK 35 Monitor/Defibrillator9933599335-000013U2025-12-18
07613327673227LIFEPAK 35 Monitor/Defibrillator9933599335-000029U2025-12-18
07613327673234LIFEPAK 35 Monitor/Defibrillator9933599335-000030U2025-12-18
07613327673241LIFEPAK 35 Monitor/Defibrillator9933599335-000033U2025-12-18
07613327673258LIFEPAK 35 Monitor/Defibrillator9933599335-000034U2025-12-18
07613327673265LIFEPAK 35 Monitor/Defibrillator9933599335-000031U2025-12-18
07613327673357LIFEPAK 35 Monitor/Defibrillator9933599335-000032U2025-12-18
07613327681864LIFEPAK 35 Monitor/Defibrillator9933599335-000028U2025-12-18
00883873760420ASSY,CABLE,ADAPTER,TEMPERATURE,M-PAK,LP35,10FT1123011230-0000282025-09-26
00883873760437ASSY, CABLE, ADAPTER, TEMP, LP35, 6FT,IRONGAN1123011230-0000272025-09-26
00883873760444ASSY, CABLE, ADAPTER, IP, ICU, LP351123011230-0000262025-09-26
00883873760451ASSY, CABLE, ADAPTER, IP, EDWARDS, LP351123011230-0000252025-09-26

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