AccessGUDID - DEVICE: Adapter Tube Set, Large Bore (10816203021639)

GUDID

Device Identifier (DI) Information

Brand Name: Adapter Tube Set, Large Bore
Version or Model: HFT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORIGEN BIOMEDICAL, INC.

Primary DI Number: 10816203021639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 625272232 *Terms of Use

Device Description: Hemofiltration Tubing Set, singly aseptically pouched

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Fluid transfer set, general-purpose	A collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KGZ	Accessories, Catheter

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
No Device Sizes

Device Record Status

Public Device Record Key: 44b37c4f-4482-4c92-9b40-a22974a21f67
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016