Curaplex - Curaplex 8in Exten Set Rmvble Sure Lok NeedleFree - TRI-ANIM HEALTH SERVICES, INC.

Duns Number:010712461

Device Description: Curaplex 8in Exten Set Rmvble Sure Lok NeedleFree Connect Pnch Clmp Rotating Male LL 1 EA Curaplex 8in Exten Set Rmvble Sure Lok NeedleFree Connect Pnch Clmp Rotating Male LL 1 EA 50EA per CS

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More Product Details

Catalog Number

1714-31081

Brand Name

Curaplex

Version/Model Number

1714-31081

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

42903e5e-cadb-4b90-9e87-af99b51ad540

Public Version Date

July 09, 2019

Public Version Number

1

DI Record Publish Date

July 01, 2019

Additional Identifiers

Package DI Number

00812277034516

Quantity per Package

50

Contains DI Package

00812277034455

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