GLOBAL HEALTHCARE - IV SET, DEHP FREE, 10 DROPS/ML, 100" LENGTH, - GHC HEALTHCARE, INC.

Duns Number:884718776

Device Description: IV SET, DEHP FREE, 10 DROPS/ML, 100" LENGTH, CONICAL SPIKE WITH AIR VENT, FLOW CONTROLLER, IV SET, DEHP FREE, 10 DROPS/ML, 100" LENGTH, CONICAL SPIKE WITH AIR VENT, FLOW CONTROLLER, TWO NEEDLE-FREE Y-PORTS, SLIDE CLAMP, ROTATING LUER LOCK CONNECTOR.

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More Product Details

Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

81-005A

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

-

Product Code Details

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

65d6da04-7658-4570-860c-91e756187eff

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

40872237008696

Quantity per Package

50

Contains DI Package

00872237008698

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"GHC HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 62