JosNoe Medical Inc - Insufflation Tubing Set with Filter, Ovate - JOSNOE MEDICAL, INC.

Duns Number:965627859

Device Description: Insufflation Tubing Set with Filter, Ovate Connector, and Luer Lock

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More Product Details

Catalog Number

-

Brand Name

JosNoe Medical Inc

Version/Model Number

JNM-OC84S

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

cf5e3611-b344-4bbb-aaf7-9f3f0e017df1

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 05, 2019

Additional Identifiers

Package DI Number

00850003294421

Quantity per Package

5

Contains DI Package

00850003294407

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"JOSNOE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15