American National - AN LEGACY PRO PUMP ONLY, - COMPASS HEALTH BRANDS CORP.

Duns Number:827221698

Device Description: AN LEGACY PRO PUMP ONLY,

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More Product Details

Catalog Number

-

Brand Name

American National

Version/Model Number

APM-AN-8000-LP-PUMP

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Device Record Status

Public Device Record Key

88015338-a9e5-4116-83ce-4afc25fddbad

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2016

Additional Identifiers

Package DI Number

30092237618166

Quantity per Package

4

Contains DI Package

00092237618165

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"COMPASS HEALTH BRANDS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 273
U Unclassified 2