AccessGUDID - DEVICE: INTERCEPT Blood System (18717953196948)

GUDID

Device Identifier (DI) Information

Brand Name: INTERCEPT Blood System
Version or Model: INT100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CERUS CORPORATION

Primary DI Number: 18717953196948
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 858999485 *Terms of Use

Device Description: INTERCEPT INT100 Illuminator

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?
44185	Pathogen inactivation/reduction system	A system to support the procedures that selectively alters pathogen surface structures and/or, in which, substances penetrate into the pathogens and irreversibly modify their nucleic acids, thereby impeding the proliferation of pathogens in liable blood products.	Obsolete	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: 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: 09f5bb28-8431-424b-9f6d-fb00d664b576
Public Version Date: April 15, 2019
Public Version Number: 4
DI Record Publish Date: January 13, 2015

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

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