AccessGUDID - DEVICE: Raycell (07540146000104)

GUDID

Device Identifier (DI) Information

Brand Name: Raycell
Version or Model: MK1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Best Theratronics Ltd

Primary DI Number: 07540146000104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243606832 *Terms of Use

Device Description: Blood Irradiator

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?
17437	In vitro ionizing-radiation blood irradiator	An electrically-powered device designed for the in vitro irradiation of blood and/or blood components with ionizing radiation [e.g., gamma, x-ray, ultraviolet C (UVC)], typically for the prevention of transfusion-associated graft-versus-host diseases and pathogen transmission, and/or for cancer treatment; some types may be additionally used to irradiate other specimen types (e.g., tissues, organs). It operates off-line (i.e. blood is not returned to the patient in a closed circuit) and typically includes a shielded, double encapsulated, long half-life radiation source (e.g., Cesium 137), blood/blood product containers, safety interlocks, a timing mechanism, and a means of retrieving samples.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOT	Irradiator, Blood To Prevent Graft Versus Host Disease

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181737	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: 8868cdb3-8d33-4cda-affe-d5a63f65526b
Public Version Date: October 04, 2024
Public Version Number: 4
DI Record Publish Date: July 16, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (613)5912100
Email: compliance@theratronics.ca

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