FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F - FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER - Intersurgical Incorporated

Duns Number:785952607

Device Description: FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F, 100MM

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More Product Details

Catalog Number

-

Brand Name

FLEXIBLE FIXED ELBOW PAEDIATRIC/NEONATAL CATHETER MOUNT, 15M - 7.6MM PORT - 15F

Version/Model Number

3532000

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

BZA

Product Code Name

Connector, Airway (Extension)

Device Record Status

Public Device Record Key

ddeac372-cc79-47fc-adb3-9dc0b06a7a94

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Additional Identifiers

Package DI Number

05030267019199

Quantity per Package

100

Contains DI Package

05030267066353

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101