FDA.reportPublic FDA data

NA

Primary DI
00883873881453
Brand
NA
Company
Jolife AB
Model
11576
Catalog number
11576-000071
Device description
LUCAS POWER SUPPLY WITHCORD,REDEL,CANADA,US
Published
2019-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MPDAuxiliary power supply (AC or DC) for low-energy dc-defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-DefibrillatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090422000LUCAS 2Jolife AB2009-06-17DRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883873881453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883873881453008838738814538838738814530883873881453

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
632662933
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00883873834282LUCAS CPR Chest Compression System9957699576-0000672024-11-08
00883873970904Lucas Battery Pack1157611576-0000392014-12-04
00883873861820LUCAS CHEST COMPRESSION SYSTEM1157611576-0000802016-11-14
00883873948286Lucas PCI Back Plate1157611576-0000642014-12-04
00883873826300LUCAS CHEST COMPRESSION SYSTEM9957699576-000063U2024-05-07
00883873826584LUCAS CHEST COMPRESSION SYSTEM9957699576-000043U2024-05-07
00883873948323NA1157611576-0000602019-04-30
00883873834329LUCAS9957699576-0000632018-03-31
00883873861875LUCAS™ CHEST COMPRESSION SYSTEM9957699576-0000432016-11-14
00883873904565LUCAS™ Chest Compression System9957699576-0000242014-12-04
00883873970898Lucas Battery Pack1157611576-0000392014-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00883873030608LIFEPAK 15 AC Power AdapterPHYSIO-CONTROL, INC.MPD2026-02-10
00883873760048SHIP KIT, POWER SUPPLY, LP35PHYSIO-CONTROL, INC.MPD2025-09-26
07613327666656LIFEPAK 15 AC Power AdapterPHYSIO-CONTROL, INC.MPD2025-02-07
00883873933459LIFEPAK 15 Replacement Right Angle Cable for AC/DC Power AdapterPHYSIO-CONTROL, INC.MPD2025-01-28
00883873933466Extension Cable for AC/DC Power AdapterPHYSIO-CONTROL, INC.MPD2025-01-28
00883873782224SHIP KIT, POWER SUPPLY,LP35PHYSIO-CONTROL, INC.MPD2024-06-20
00883873784921CHARGER, BATTERY, LP35PHYSIO-CONTROL, INC.MPD2024-06-20
00883873940112NAPHYSIO-CONTROL, INC.MPD2019-04-30
00883873940204NAPHYSIO-CONTROL, INC.MPD2019-04-30