Medline ReNewal - MANIFOLD, FOUR PORT, NEP2, REPROCESSED - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: MANIFOLD, FOUR PORT, NEP2, REPROCESSED

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More Product Details

Catalog Number

N2FOURPORTR

Brand Name

Medline ReNewal

Version/Model Number

N2FOURPORTR

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"

-

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

BYZ

Product Code Name

TRAP, STERILE SPECIMEN

Device Record Status

Public Device Record Key

b8607e1b-6dc8-4faf-b5fa-9b7e8ee90c19

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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