Medovations® - Flexible Yankauer Suction Tube, Regular Capacity - DIVERSATEK HEALTHCARE, INC.

Duns Number:030650113

Device Description: Flexible Yankauer Suction Tube, Regular Capacity

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More Product Details

Catalog Number

1284-01

Brand Name

Medovations®

Version/Model Number

1284-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Device Record Status

Public Device Record Key

1666f49a-dacd-4631-9f43-753da5b06213

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

September 07, 2018

Additional Identifiers

Package DI Number

M7831284011

Quantity per Package

50

Contains DI Package

M7831284010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"DIVERSATEK HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 207