N/A - FLAT PNL MON ARM SET-COMPACT CART 80225 - PENTAX OF AMERICA, INC.

Duns Number:083211284

Device Description: FLAT PNL MON ARM SET-COMPACT CART 80225

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

80230

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)

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

BZN

Product Code Name

Cart, Emergency, Cardiopulmonary (Excluding Equipment)

Device Record Status

Public Device Record Key

c4051c6b-c480-44ef-98b0-f4a7ad6f1549

Public Version Date

April 02, 2018

Public Version Number

1

DI Record Publish Date

March 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PENTAX OF AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 247
2 A medical device with a moderate to high risk that requires special controls. 425