AccessGUDID - DEVICE: BIOSITE/BIOSITE PLUS (B134JR009HU2)

GUDID

Device Identifier (DI) Information

Brand Name: BIOSITE/BIOSITE PLUS
Version or Model: JR-009-HU
Commercial Distribution Status: In Commercial Distribution
Catalog Number: JR-009-HU
Company Name: MACLIN POWER, INC.

Primary DI Number: B134JR009HU2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 962650714 *Terms of Use

Device Description: JR-009-HU 300 PSI High-Pressure Needleless Neutral Valve

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":	Yes
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?
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 8b7a5fd6-a79c-4c52-9cbe-1caa5f58b573
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 30, 2016