AccessGUDID - DEVICE: CARDINAL HEALTH (10885380126413)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: LB18ET
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LB18ET
Company Name: CARDINAL HEALTH 200, LLC

Primary DI Number: 10885380126413
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112164780 *Terms of Use

Device Description: Extension Tubing with Connector; 18 in.

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?
42988	Low-pressure tubing connector, reusable	A device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYY	TUBE, ASPIRATING, FLEXIBLE, CONNECTING

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
Height: 18 Inch

Device Record Status

Public Device Record Key: 8b27fb7d-f37a-4864-9c04-f91386f6f9c4
Public Version Date: July 29, 2019
Public Version Number: 1
DI Record Publish Date: July 19, 2019