Biomedix B72 SELEC-3+NIS+LAS IV ADM. SET - B72 SELEC-3+NIS+LAS IV ADM. SET - BIOMEDIX-INC

Duns Number:798045530

Device Description: B72 SELEC-3+NIS+LAS IV ADM. SET

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More Product Details

Catalog Number

-

Brand Name

Biomedix B72 SELEC-3+NIS+LAS IV ADM. SET

Version/Model Number

B72-102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Device Record Status

Public Device Record Key

68797c1c-fcab-4b94-b69f-fd60b7c14589

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMEDIX-INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16