Curaplex - Curaplex Slct IV Admin Set, 15Dp,89in,Rlr Clmp,PP - TRI-ANIM HEALTH SERVICES, INC.

Duns Number:010712461

Device Description: Curaplex Slct IV Admin Set, 15Dp,89in,Rlr Clmp,PP Ysite,Sr-Lk NdleFr Y, Attch Ext Set, 1/ Curaplex Slct IV Admin Set, 15Dp,89in,Rlr Clmp,PP Ysite,Sr-Lk NdleFr Y, Attch Ext Set, 1/EA 50EA/CS

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More Product Details

Catalog Number

1712-15830

Brand Name

Curaplex

Version/Model Number

1712-15830

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)

-

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

65069528-fec6-43e8-8ad2-34a2d158dbc6

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

July 01, 2019

Additional Identifiers

Package DI Number

00812277034547

Quantity per Package

50

Contains DI Package

00812277034486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"TRI-ANIM HEALTH SERVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 92
2 A medical device with a moderate to high risk that requires special controls. 92