AccessGUDID - DEVICE: SPIKE, BLOOD W/ 1/4" CONNECTOR COVER (B0663011030000)

GUDID

Device Identifier (DI) Information

Brand Name: SPIKE, BLOOD W/ 1/4" CONNECTOR COVER
Version or Model: 301103-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 301103-000
Company Name: NOVOSCI CORP.

Primary DI Number: B0663011030000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58977	Basic intravenous administration set, noninvasive	A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7dd302d7-d908-4387-ab5e-95b47e5b2655
Public Version Date: June 20, 2023
Public Version Number: 3
DI Record Publish Date: October 12, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B0663011030007	75	B0663011030000	In Commercial Distribution	PARTIAL CASE
B0663011030006	50	B0663011030000	In Commercial Distribution	PARTIAL CASE
B0663011030005	100	B0663011030000	In Commercial Distribution	CASE
B0663011030003	25	B0663011030000	In Commercial Distribution	INNER CARTON