7.2 Ah Li-ion Battery - BATTERY PACK,LITHIUM-ION,LP12 - PHYSIO-CONTROL, INC.

Duns Number:009251992

Device Description: BATTERY PACK,LITHIUM-ION,LP12

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More Product Details

Catalog Number

11141-000106

Brand Name

7.2 Ah Li-ion Battery

Version/Model Number

11141

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

-

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

37cda544-de1f-497c-ada6-608046b265bb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 10, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHYSIO-CONTROL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 76
3 A medical device with high risk that requires premarket approval 588