AccessGUDID - DEVICE: RM3 Tool Kit (B154R39100010043)

GUDID

Device Identifier (DI) Information

Brand Name: RM3 Tool Kit
Version or Model: RM3 Tool Kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3910001.004
Company Name: WATERS MEDICAL SYSTEMS, LLC

Primary DI Number: B154R39100010043
Issuing Agency: HIBCC
Commercial Distribution End Date: December 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 556957871 *Terms of Use

Device Description: RM3 Tool Kit

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:	No
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: No
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: 91f2c804-3a6f-4061-8fd1-ff414755e0f4
Public Version Date: December 18, 2023
Public Version Number: 5
DI Record Publish Date: March 27, 2017