AccessGUDID - DEVICE: INTERCEPT Blood System for Platelets (18717953196979)

GUDID

Device Identifier (DI) Information

Brand Name: INTERCEPT Blood System for Platelets
Version or Model: INT2530B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CERUS CORPORATION

Primary DI Number: 18717953196979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 858999485 *Terms of Use

Device Description: INTERCEPT Blood System for Platelets Dual Storage (DS) 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: a3124ef8-b7ce-45f3-afca-4a3a93e8efe1
Public Version Date: April 15, 2019
Public Version Number: 4
DI Record Publish Date: May 07, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
28717953196976	4	18717953196979		In Commercial Distribution	Shipping Carton Box

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 08717953196972 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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-855-835-3523
Email: xxx@xxx.xxx

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