DDU-1XXX/2XXX Series Battery Pack - DEFIBTECH, L.L.C.

Duns Number:128340200

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More Product Details

Catalog Number

-

Brand Name

DDU-1XXX/2XXX Series Battery Pack

Version/Model Number

DBP-2013

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081259

Product Code Details

Product Code

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Device Record Status

Public Device Record Key

f4a17bc8-5e2a-464b-921c-2a6911a9814e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEFIBTECH, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 13
3 A medical device with high risk that requires premarket approval 68