AccessGUDID - DEVICE: RADGIL2 (B850033600040)

GUDID

Device Identifier (DI) Information

Brand Name: RADGIL2
Version or Model: RADGIL2 US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03360004
Company Name: GILARDONI SPA

Primary DI Number: B850033600040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429002678 *Terms of Use

Device Description: x rays 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):	No
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 [?]
K201177	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
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: less than 80 Percent (%) Relative Humidity
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8b947063-5b53-4a71-8013-4fdb91d65a85
Public Version Date: October 04, 2024
Public Version Number: 3
DI Record Publish Date: June 14, 2021

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: +39341775011
Email: DANIELE.MAGGIONI@GILARDONI.IT

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