AccessGUDID - DEVICE: KENAFLEXX (00810003750099)

GUDID

Device Identifier (DI) Information

Brand Name: KENAFLEXX
Version or Model: 940014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 940014
Company Name: KENTRON HEALTHCARE, INC.

Primary DI Number: 00810003750099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618825723 *Terms of Use

Device Description: 12" IV EXTENSION SET WITH FEMALE LUER, KENTRON GRAVITO FLOW CONTROLLER, ONE KEN_FLO Y SITE, ONE KEN_SEF SPLIT SEPTUM Y SITE, SLIDING CLAMP, KEN_ROL MALE ROTATING LUER LOCK CONNECTOR.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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
LHI	Set, I.V. Fluid Transfer

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: 12 Inch

Device Record Status

Public Device Record Key: 9adb4ec4-1817-49fb-9528-ae2e39e61bff
Public Version Date: December 19, 2018
Public Version Number: 1
DI Record Publish Date: November 18, 2018