S&W 90101-RC

GUDID 30869956000028

Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring

Leonhard Lang GmbH

Multifunction cardiac electrode
Primary Device ID30869956000028
NIH Device Record Keya2b2078b-6bf9-4fea-9493-d4ee53ec61a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameS&W
Version Model NumberDF20NC
Catalog Number90101-RC
Company DUNS302846407
Company NameLeonhard Lang GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110869956000024 [Primary]
GS120869956000021 [Package]
Contains: 10869956000024
Package: box [10 Units]
In Commercial Distribution
GS130869956000028 [Package]
Contains: 20869956000021
Package: box [6 Units]
In Commercial Distribution

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-04-04
Device Publish Date2014-09-23

On-Brand Devices [S&W]

30869956000066Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
30869956000059Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
30869956000042Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
30869956000035Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
30869956000028Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
20869956000014Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.