SPIKE, BLOOD W/ 1/4" CONN COVER - A small, sterile device intended to connect an - NOVOSCI CORP.

Duns Number:938289980

Device Description: A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.

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More Product Details

Catalog Number

301103NS

Brand Name

SPIKE, BLOOD W/ 1/4" CONN COVER

Version/Model Number

301103NS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

DTL

Product Code Name

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

e8ee293c-e1e6-40cf-b729-817bef589439

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 13, 2015

Additional Identifiers

Package DI Number

B066301103NS5

Quantity per Package

1000

Contains DI Package

B066301103NS1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"NOVOSCI CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50