Zyno - BX Administration Primary Set: 105" 1 NF Y Site - ZYNO MEDICAL LLC

Duns Number:030899271

Device Description: BX Administration Primary Set: 105" 1 NF Y Site Below Pump, 1.2 Filter, Anti-Free Flow Cl BX Administration Primary Set: 105" 1 NF Y Site Below Pump, 1.2 Filter, Anti-Free Flow Clamp. BX Primary Administration Sets are single-use IV administration sets for use with Z-800F, Z-800W and Z-800WF Zyno Medical Infusion pumps. All BX Primary sets fluid paths are sterile, non-Pyrogenic, are not made with natural rubber latex, and are not made with DEHP.

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More Product Details

Catalog Number

BX-70071-DF-120

Brand Name

Zyno

Version/Model Number

BX-70071-DF-120

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

K120685,K120685,K120685

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

38ace439-af82-4379-875f-c32bab34373d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20814371020550

Quantity per Package

6

Contains DI Package

10814371020553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ZYNO MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19