FDA UDI
In Commercial Distribution
🇺🇸 United States
RS
DI: 00860000737005
·
Model: 3400
·
RAD SOURCE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- RS
- Primary DI
- 00860000737005
- Version / Model
- 3400
- Company Name
- RAD SOURCE TECHNOLOGIES, INC.
- Labeler DUNS
- 047783811
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-29
- Public Version
- 4
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- 78c96013-beaa-4268-94e2-4782f1f445f2
Device Description
Blood Irradiator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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), 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860000737005 | GS1 |
Customer Contacts
- Phone
- 678-765-7900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082921 | 000 |