AccessGUDID - DEVICE: DCM-100 DUAL KIDNEY CASSETTE (B154R00126910000)

GUDID

Device Identifier (DI) Information

Brand Name: DCM-100 DUAL KIDNEY CASSETTE
Version or Model: DCM Kidney Cassette
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0012691.000
Company Name: WATERS MEDICAL SYSTEMS, LLC

Primary DI Number: B154R00126910000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556957871 *Terms of Use

Device Description: The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one or two kidneys. The kidneys are attached to the arterial ports either in single fashion, or can be placed enbloc.

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):	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?
48039	Kidney donor-organ preservation/transport perfusion set	A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDN	System, Perfusion, Kidney

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971571	000

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: ad7f8d59-ed95-495c-8c4e-b0ba5b415996
Public Version Date: March 20, 2019
Public Version Number: 4
DI Record Publish Date: February 12, 2017