Pacific West Medical - The Pacific West Pediatric (Infant) - PACIFIC WEST MEDICAL, INC.

Duns Number:926938275

Device Description: The Pacific West Pediatric (Infant) Radiotranslucent Multifunction Electrodes are indicate

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More Product Details

Catalog Number

PWMINFANT-Philips

Brand Name

Pacific West Medical

Version/Model Number

PWMINFANT-Philips

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

LDD

Product Code Name

Dc-Defibrillator, Low-Energy, (Including Paddles)

Device Record Status

Public Device Record Key

71f79ac0-6712-4487-ba7e-36790c3cf358

Public Version Date

May 04, 2018

Public Version Number

1

DI Record Publish Date

April 03, 2018

Additional Identifiers

Package DI Number

00852397008042

Quantity per Package

10

Contains DI Package

00852397008035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case