Little Sucker Preemie with Cover - Oral-Nasal Suction Device - Neotech Products LLC

Duns Number:198013435

Device Description: Oral-Nasal Suction Device

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More Product Details

Catalog Number

N204C

Brand Name

Little Sucker Preemie with Cover

Version/Model Number

10812594011365

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"

Yes

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

JOL

Product Code Name

Catheter And Tip, Suction

Device Record Status

Public Device Record Key

92a03933-beff-418c-b728-d9fd497fe4c0

Public Version Date

July 26, 2022

Public Version Number

5

DI Record Publish Date

February 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEOTECH PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 153
2 A medical device with a moderate to high risk that requires special controls. 27