FDA UDI
In Commercial Distribution
🇺🇸 United States
TD 200®
DI: B205CSTD2001
·
Model: TD 200
·
CS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TD 200®
- Primary DI
- B205CSTD2001
- Version / Model
- TD 200
- Catalog Number
- CS-TD-200
- Company Name
- CS MEDICAL, LLC
- Labeler DUNS
- 603864294
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-15
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 8787cc5d-fca1-4d79-9857-5c8953680ffc
Device Description
TD 200® Automated TEE Probe Disinfector
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 |
|---|---|---|---|---|
| PSW | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61673 | Ultrasound imaging transducer washer-disinfector (chemical) | A dedicated electrically-powered unit intended to be used to wash and disinfect ultrasound imaging transducers with the use of appropriate cleaning methods and chemical disinfection. It is typically a stand-alone unit with a washing/disinfecting chamber designed to accept an ultrasound imaging transducer (probe). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B205CSTD2001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192228 | 000 |