FDA UDI
Not in Commercial Distribution
🇺🇸 United States
COBE® Spectra
DI: 05020583706293
·
Model: 70629
·
TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- COBE® Spectra
- Primary DI
- 05020583706293
- Version / Model
- 70629
- Company Name
- TERUMO BCT, INC.
- Labeler DUNS
- 801679200
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 8
- Public Version Date
- 2024-05-27
- Public Version Status
- Update
- Public Device Record Key
- 975038b1-02fb-4bb1-94bc-90bf5f8deb9b
- Distribution End Date
- 2019-03-01
Device Description
White Blood Cell-Functionally Closed Tubing
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 | 05020583706293 | GS1 | ||||
| Package | 35020583706294 | GS1 | 6 | Not in Commercial Distribution | 2019-03-01 |
Customer Contacts
- Phone
- +1(877)339-4228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK020041 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from rain
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius