AccessGUDID - DEVICE: FK30106G (00850005864202)

GUDID

Device Identifier (DI) Information

Brand Name: FK30106G
Version or Model: FK30106G
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PATHEN MEDICAL LLC

Primary DI Number: 00850005864202
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042928915 *Terms of Use

Device Description: 106" (269cm) Universal 20 drop spike, back check valve (BCV), 2 needle-free Y-sites 90" and 10" above distal end, slide clamp, roller clamp, male spin luer lock

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?
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: 7829feff-a3f3-41de-80b7-c04c1911b110
Public Version Date: April 05, 2019
Public Version Number: 1
DI Record Publish Date: March 28, 2019