AccessGUDID - DEVICE: INTERCEPT Blood System for Platelets (18717953196900)

GUDID

Device Identifier (DI) Information

Brand Name: INTERCEPT Blood System for Platelets
Version or Model: INT2110B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CERUS CORPORATION

Primary DI Number: 18717953196900
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2019
Device Count: 6
Labeler D-U-N-S® Number*: 858999485 *Terms of Use

Device Description: INTERCEPT Blood System Platelets Small Volume (SV) Processing Set

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63003	Donor blood photochemical treatment kit	A collection of sterile devices and reagent solution intended to be used in vitro with an ultraviolet (UV) blood illuminator for photochemical treatment of donor blood (including whole blood, plasma, and/or platelet concentrates) to inactivate blood transfusion-associated pathogens and white blood cells, and for subsequent storage. It includes plastic illumination and storage bags and tubing, and a photoactive reagent (e.g., riboflavin, psoralen) solution; a sampling bag for quality control and a compound adsorption device used post-irradiation to reduce the levels of photoactive reagent in the final suspension may be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJF	Illuminator System For Blood Products

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: abdd14bf-bd48-4876-94ac-77ebd16bbe52
Public Version Date: February 20, 2023
Public Version Number: 5
DI Record Publish Date: January 13, 2015