S&W - Multifunction electrode for defibrillation, - Leonhard Lang GmbH

Duns Number:302846407

Device Description: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring

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More Product Details

Catalog Number

90303

Brand Name

S&W

Version/Model Number

DF27N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Device Record Status

Public Device Record Key

80776747-5daf-45d4-a2cb-1bf74b897c05

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2014

Additional Identifiers

Package DI Number

30869956000035

Quantity per Package

6

Contains DI Package

20869956000038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"LEONHARD LANG GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9
3 A medical device with high risk that requires premarket approval 17