Catalog Number

-

Brand Name

Invacare® Aspirator

Version/Model Number

1072000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

80849f57-c2d3-498e-9ca9-5386d470cd28

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 27, 2017

Package DI Number

20841447100816

Quantity per Package

70

Contains DI Package

00841447100812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE