FDA.reportPublic FDA data

PEDIATRIC PADDLE ADAPTER

Primary DI
00681490587853
Brand
PEDIATRIC PADDLE ADAPTER
Company
PHYSIO-CONTROL, INC.
Model
11133
Catalog number
11133-000001
Device description
PEDIATRIC PADDLE ASSY,ENG, 3RD EDITION
Published
2015-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDDDc-defibrillator, low-energy, (including paddles)
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

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
00681490587853PrimaryGS10
00883873796146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00681490587853006814905878536814905878530681490587853
00883873796146008838737961468838737961460883873796146

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode, paediatric, reusableAn electrical conductor used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It usually consists of a cable set that terminates with small-diameter, hand-operated electrodes (paddles) that are held by the operator to the chest (the intact torso) of the patient so that the discharge passes across the region of the heart. Typically available as a set of two electrodes with a combined cable/connector, or as a single electrode with cable/connector, in which case two will be connected to the external pulse generator (EPG). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
009251992
Device count
1
Lot or batch
true
Manufacturing date on label
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
00883873030608LIFEPAK 15 AC Power Adapter4157741577-0003332026-02-10
07613327666656LIFEPAK 15 AC Power Adapter1114011140-0000982025-02-07
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
07613327691344LIFEPAK 35 Monitor/Defibrillator9633596335-000000U2025-12-18
07613327691351LIFEPAK 35 Monitor/Defibrillator9633596335-000001U2025-12-18
00883873760031BATTERY, LI-ION, LP351114111141-0001742025-09-26

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Primary DI, Brand, Company table
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