LSP - Aspirator - ALLIED HEALTHCARE PRODUCTS, INC.

Duns Number:099674145

Device Description: Aspirator

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More Product Details

Catalog Number

L474-010

Brand Name

LSP

Version/Model Number

L474-010

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

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

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

115d3fa7-171b-4c78-af99-aa75b22efe4b

Public Version Date

May 11, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

40026072011421

Quantity per Package

10

Contains DI Package

00026072011423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ALLIED HEALTHCARE PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 1099