FDA UDI
In Commercial Distribution
🇺🇸 United States
MTS
DI: 10758750005802
·
Model: MTS5150-60
·
MICRO TYPING SYSTEMS, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MTS
- Primary DI
- 10758750005802
- Version / Model
- MTS5150-60
- Catalog Number
- MTS515060
- Company Name
- MICRO TYPING SYSTEMS, INC
- Labeler DUNS
- 781421888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 4
- Public Version Date
- 2023-07-20
- Public Version Status
- Update
- Public Device Record Key
- 0a886d9c-1b22-48ae-b1bb-47c8243c54b4
Device Description
MTS™ Centrifuge model 5150-60
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| KSN | CENTRIFUGE, CELL-WASHING, AUTOMATED FOR IMMUNO-HEMATOLOGY | Hematology | 864.9285 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66230 | Gel column agglutination centrifuge IVD | An electrically-powered device intended to be used in a clinical laboratory setting for the centrifugation of gel column agglutination cards used to perform manual blood typing assays. It is a dedicated compact benchtop unit with an electric motor, a shaft, a rotor with slots specifically shaped for use with gel column cards, and speed and time controls. The device is intended to centrifuge gel column agglutination cards for the manual determination of antigens of multiple blood systems (e.g., ABO, Rh, Kell) for compatibility testing and detection of unexpected antibodies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750005802 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius