Medline - 3ML ENFIT SYRINGE, AMBER - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: 3ML ENFIT SYRINGE, AMBER

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More Product Details

Catalog Number

NON66203

Brand Name

Medline

Version/Model Number

NON66203

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

K190502,K190502

Product Code Details

Product Code

PNR

Product Code Name

Enteral Syringes with enteral specific connectors

Device Record Status

Public Device Record Key

a8506fbe-7fa2-4361-a1bd-0033a5fb96d0

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

December 09, 2020

Additional Identifiers

Package DI Number

20888277703671

Quantity per Package

500

Contains DI Package

10888277703674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7