MediChoice - Tubing Insufflation 0.1 Micron Filter Luer Funnel - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Tubing Insufflation 0.1 Micron Filter Luer Funnel Connect Stryker DEHP-Free Polyvinyl Chlo Tubing Insufflation 0.1 Micron Filter Luer Funnel Connect Stryker DEHP-Free Polyvinyl Chloride 10 Feet Sterile Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

INSF1003

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

NKC

Product Code Name

Tubing/tubing with filter, insufflation, laparoscopic

Device Record Status

Public Device Record Key

11e448f5-9812-486c-b7ea-6993bbcde5d6

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2020

Additional Identifiers

Package DI Number

30885632112939

Quantity per Package

10

Contains DI Package

10885632112935

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1