FDA.reportPublic FDA data

S&W

Primary DI
10869956000048
Brand
S&W
Company
Leonhard Lang GmbH
Model
DF27NC
Catalog number
90303-RC
Device description
Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20869956000045PackageGS110In Commercial Distribution
30869956000042PackageGS16In Commercial Distribution
10869956000048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086995600004520869956000045
3086995600004230869956000042
1086995600004810869956000048

GMDN Terms#

Term, Definition table
TermDefinition
Multifunction cardiac treatment electrodeAn electrical conductor designed to be applied to an adult and/or paediatric patient for automatic or manual defibrillation, external pacing, and cardioversion through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses (e.g., defibrillator); it commonly will also be used for electrocardiographic monitoring. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
302846407
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19005531002767SkintactPU-TC1CPU-TC1C2026-01-15
29005531002764SkintactPU-TC1CPU-TC1C2026-01-15
19005531003047SkintactFLEX-TC1CFLEX-TC1C2026-01-14
29005531003044SkintactFLEX-TC1CFLEX-TC1C2026-01-14
10869956000017S&WDF20N901012014-09-23
10869956000024S&WDF20NC90101-RC2014-09-23
10869956000031S&WDF27N903032014-09-23
10869956000055S&WDF28N904042014-09-23
10869956000062S&WDF28NC90404-RC2014-09-23
19005531500256SkintactDF26N2014-09-19
19005531500287SkintactDF29NDF29N2014-09-19
19005531501130SkintactDF20NDF20N2014-09-23
19005531501161SkintactDF28NDF28N2014-09-23
19005531502458SkintactDF28NCDF28NC2014-09-23
19005531502915SkintactDF20NCDF20NC2014-09-23
19005531504605GE HealthcareDF55N2059145-0012015-04-14
19005531506067SkintactDF27NCDF27NC2014-09-23
19005531506388SkintactDF27NDF27N2014-09-23
19005531506432SkintactDF59NDF59N2015-03-20
19005531506449SkintactDF59NCDF59NC2015-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
20192253017516KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017530KendallCardinal Health 200, LLCMKJ2024-02-28
20192253017561Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
20192253017608Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
10009336010322Zoll PL DefibGRAPHIC CONTROLS ACQUISITION CORPMKJ2023-10-30
10653405046813CONMEDConmed CorporationMKJ2023-10-19
20192253017714KendallCardinal Health 200, LLCMKJ2023-06-15
10884838002859HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-02-25
10884838002842HeartStart Adult/Child Plus PadsPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838002866HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838022048Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
20192253017554Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017622Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253018865Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
20192253017578Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017585Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017639Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018872Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253018889Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017547Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-28
20192253017295KendallCardinal Health 200, LLCMKJ2021-05-06
20192253017455KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017721KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017745KendallCardinal Health 200, LLCMKJ2021-05-05