AccessGUDID - DEVICE: Henry Schein (10304040180270)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 5703714
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5703714
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 10304040180270
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Blood Control Safety IV Catheters are ergonomically designed with contoured catheter housing and a textured hub that creates a non-slip grip for easy handling. The Blood Control Safety IV Catheters feature a triple-facet, bevel needle with a fully encapsulating needle shield that encases the needle upon full retraction, providing safety without compromising functionality.

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?
18067	Intravenous line recessed-needle connector	A sterile device designed to allow access to either the Y-site of an intravenous (IV) line or an injection adaptor on the infusion catheter. Typically, a needle located inside a plastic housing can be inserted into a standard septum and a Luer fitting located at the opposite end allows the connection of a syringe or infusion set. A manual or automated mechanism moves the housing to protect the operator from the needle once the infusion is finished. The device is intended to eliminate an exposed needle after administration of medications. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days

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: fa6dab5a-2569-479a-ad8e-25b90f32d7fa
Public Version Date: May 29, 2024
Public Version Number: 1
DI Record Publish Date: May 21, 2024