FDA UDI
In Commercial Distribution
🇺🇸 United States
TSCD
DI: 04987350726971
·
Model: SC*W017
·
TERUMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
70
Basic Information
- Brand Name
- TSCD
- Primary DI
- 04987350726971
- Version / Model
- SC*W017
- Company Name
- TERUMO CORPORATION
- Labeler DUNS
- 690543319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 70
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 984d3f34-0fb1-4bd5-b897-0f6b39e47dcd
Device Description
TSCD Wafers
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 34987350726972 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 04987350726971 | GS1 | ||||
| Package | 54987350726976 | GS1 | 40 | In Commercial Distribution | ||
| Unit of Use | 84987350726977 | GS1 |
Customer Contacts
- Phone
- +1(303)205-2510
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- non-condensing, This way up, Fragile, handle with care, Stacking limit by 10, Keep away from sunlight, Keep dry