Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

88-350D

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K960492

Product Code

BTA

Product Code Name

PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Public Device Record Key

21f0a7c5-db86-4519-b5ec-54d0c0de0708

Public Version Date

August 11, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-