FDA UDI
In Commercial Distribution
🇺🇸 United States
TSCD® II
DI: 05020583300033
·
Model: 3MESC203A
·
TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TSCD® II
- Primary DI
- 05020583300033
- Version / Model
- 3MESC203A
- Company Name
- TERUMO BCT, INC.
- Labeler DUNS
- 801679200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 6
- Public Version Date
- 2023-09-27
- Public Version Status
- Update
- Public Device Record Key
- 63e4b203-10f8-4ead-bf08-b9eedf80913d
Device Description
Sterile Tubing Welder
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KSB | SET, TRANSFER (BLOOD/PLASMA) | Hematology | 864.9875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36674 | Package sealing unit | A mains electricity (AC-powered) device intended to be used for sealing packaged products and utensils, e.g., blood products, test tubes or sterilized instruments/equipment, through the application of heat upon the packaging materials to create an airtight seal. It is typically used in operating room (OR) departments, sterile packaging centres, and laboratories. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05020583300033 | GS1 |
Customer Contacts
- Phone
- +1(877)339-4228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK110071 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from rain
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight.