APG Air-Plethysmograph - Pneumatic plethysmograph. - ACI MEDICAL LLC

Duns Number:153761499

Device Description: Pneumatic plethysmograph.

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More Product Details

Catalog Number

APG-1000

Brand Name

APG Air-Plethysmograph

Version/Model Number

APG-1000

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

K881291

Product Code Details

Product Code

JOM

Product Code Name

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Device Record Status

Public Device Record Key

425f2d88-00a7-4632-9891-a19ff29ff9f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACI MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3