FDA UDI
In Commercial Distribution
🇺🇸 United States
COBE® Spectra
DI: 05020583705005
·
Model: 70500
·
TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- COBE® Spectra
- Primary DI
- 05020583705005
- Version / Model
- 70500
- Catalog Number
- 70500
- Company Name
- TERUMO BCT, INC.
- Labeler DUNS
- 801679200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-07
- Public Version
- 6
- Public Version Date
- 2024-05-27
- Public Version Status
- Update
- Public Device Record Key
- ea593fdd-e9d1-43fc-b844-59fd606beb19
Device Description
Therapeutic Plasma Exchange Set
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44903 | Blood transfer set | A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05020583705005 | GS1 | ||||
| Package | 35020583705006 | GS1 | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1 877-339-4228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK900002 | 0 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from rain.