Extension line doble Luer Lock 1.7x3.0x23mm - Promepla

Duns Number:401020409

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More Product Details

Catalog Number

ODG0015USST

Brand Name

Extension line doble Luer Lock 1.7x3.0x23mm

Version/Model Number

ODG0015USST

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

KYX

Product Code Name

Dispenser, Liquid Medication

Device Record Status

Public Device Record Key

2a68f3de-a3db-4775-bfb1-3f6ab2c7d90d

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

April 03, 2020

Additional Identifiers

Package DI Number

03700512925200

Quantity per Package

100

Contains DI Package

03700512952022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"PROMEPLA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 64
2 A medical device with a moderate to high risk that requires special controls. 152