FDA UDI
In Commercial Distribution
🇺🇸 United States
TD-5®
DI: B205TD5A1
·
Model: TD-5
·
CS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
32
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Basic Information
- Brand Name
- TD-5®
- Primary DI
- B205TD5A1
- Version / Model
- TD-5
- Catalog Number
- CS-TD-5
- Company Name
- CS MEDICAL, LLC
- Labeler DUNS
- 603864294
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 32
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 96b43b16-4281-45e0-b034-50fff67a6ce4
Device Description
TD-5® High Level Disinfectant
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40579 | Glutaraldehyde device sterilant | A liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B205TD5A1 | HIBCC | ||||
| Unit of Use | B205TD5A0 | HIBCC |
Customer Contacts
- Phone
- 919-255-9472
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051305 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius