RS

Primary DI
00860000737005
Brand
RS
Company
RAD SOURCE TECHNOLOGIES, INC.
Model
3400
Device description
Blood Irradiator
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOTIrradiator, Blood To Prevent Graft Versus Host Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOTIrradiator, Blood To Prevent Graft Versus Host DiseaseUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082921000RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400Rad Source Technologies, Inc.2009-02-17MOT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000737005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000737005008600007370058600007370050860000737005

GMDN Terms#

Term, Definition table
TermDefinition
Ionizing-radiation blood irradiatorA mains electricity (AC-powered) device assembly designed for the in vitro irradiation of blood and/or blood components with ionizing radiation (e.g., gamma), typically used to treat cancer patients by inactivating lymphocytes and for the prevention of transfusion-associated graft-versus-host diseases. It 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
678-765-7900compliance@radsource.com

Regulatory Flags#

DUNS number
047783811
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B850033600040RADGIL2GILARDONI SPAMOT2021-06-14
07540146000104RaycellBest Theratronics LtdMOT2019-07-16
00754014600106RaycellBest Theratronics LtdMOT2019-07-16
07540146000012GammacellBest Theratronics LtdMOT2016-09-24
07540146000029GammacellBest Theratronics LtdMOT2016-09-24
07540146000043RaycellBest Theratronics LtdMOT2016-09-24
00754014600014GammacellBest Theratronics LtdMOT2016-09-24
00754014600021GammacellBest Theratronics LtdMOT2016-09-24
00754014600045RaycellBest Theratronics LtdMOT2016-09-24