FDA UDI
In Commercial Distribution
🇺🇸 United States
SCD Welding Wafer
DI: 35020583260314
·
Model: 3NCC987
·
TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
70
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Basic Information
- Brand Name
- SCD Welding Wafer
- Primary DI
- 35020583260314
- Version / Model
- 3NCC987
- Company Name
- TERUMO BCT, INC.
- Labeler DUNS
- 801679200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 70
- Record Status
- Published
- Publish Date
- 2025-05-14
- Public Version
- 2
- Public Version Date
- 2025-05-29
- Public Version Status
- Update
- Public Device Record Key
- e070c8bc-93a5-4dca-b080-12e3f69462a1
Device Description
3-NCC987 SCD Wafer
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 55020583260318 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 35020583260314 | GS1 | ||||
| Unit of Use | 05020583260313 | GS1 |
Customer Contacts
- Phone
- +1(877)339-4228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK860041 | 0 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 54 Degrees Celsius