AccessGUDID - DEVICE: Thermo Scientific (10850685007002)

GUDID

Device Identifier (DI) Information

Brand Name: Thermo Scientific
Version or Model: CW3 Cell Washer
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 75007504
Company Name: Thermo Electron LED GmbH

Primary DI Number: 10850685007002
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 537396330 *Terms of Use

Device Description: No description.

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):	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?
35901	Cell washer IVD	An automated mains electricity (AC-powered) laboratory instrument intended to be used to separate red blood cells from whole blood and wash the intact red blood cells, typically through low-speed centrifugal force, to remove plasma, debris and/or any other extraneous material so they are free from interfering substances and suitable for use in subsequent in vitro clinical testing (e.g., antiglobulin). The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK160044	0

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: cc087ad4-6805-4439-b25e-4314564f1ef7
Public Version Date: June 21, 2023
Public Version Number: 4
DI Record Publish Date: March 24, 2017