Alcor SENTINELplus - Enteral Feeding Gravity Set, ENFit, secure lock - ALCOR SCIENTIFIC INC.

Duns Number:884153748

Device Description: Enteral Feeding Gravity Set, ENFit, secure lock tip, adapter, NS

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More Product Details

Catalog Number

EN-1203SP

Brand Name

Alcor SENTINELplus

Version/Model Number

EN-1203SP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 23, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K902729

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

38e5bb8f-0686-4d39-80a2-8b07280fc2e3

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

March 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALCOR SCIENTIFIC INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 20