AccessGUDID - DEVICE: IV Extension Set 6" (00850014433130)

GUDID

Device Identifier (DI) Information

Brand Name: IV Extension Set 6"
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DU2260
Company Name: DISTRIBUTION UNLIMITED, LLC

Primary DI Number: 00850014433130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 926603486 *Terms of Use

Device Description: are connected to IV catheters to allow a larger distance between the patient and the fluid being administered which is often necessary due to the size and volume of equipment being used at any one time

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):	No
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
Length: 6 Inch
Device Size Text, specify: Small Bore

Device Record Status

Public Device Record Key: a6c645a9-1c53-4132-89ec-8580f3a18bd5
Public Version Date: February 20, 2023
Public Version Number: 2
DI Record Publish Date: August 19, 2020