neria™soft - Single use infusion set for subcutaneous - Unomedical A/S

Duns Number:306032491

Device Description: Single use infusion set for subcutaneous infusion. The infusion set must be used as descri Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

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More Product Details

Catalog Number

-

Brand Name

neria™soft

Version/Model Number

79-110-2622

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

4790690e-f249-4fdf-a590-aed0462cfcf1

Public Version Date

March 12, 2020

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

05705244001145

Quantity per Package

200

Contains DI Package

05705244001138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer box

"UNOMEDICAL A/S" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14