FDA UDI
In Commercial Distribution
🇺🇸 United States
TERUFLEX BLOOD BAG
DI: 04987350702654
·
Model: BB*D606Ａ
·
TERUMO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TERUFLEX BLOOD BAG
- Primary DI
- 04987350702654
- Version / Model
- BB*D606Ａ
- Company Name
- TERUMO CORPORATION
- Labeler DUNS
- 690543319
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 3
- Public Version Date
- 2022-06-17
- Public Version Status
- Update
- Public Device Record Key
- 90aa85fa-74d8-4989-a30a-3b303524a903
Device Description
TERUFLEX BLOOD BAG WITHOUT ANTICOAGULANT
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 |
|---|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Hematology | 864.9100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44904 | Blood/tissue storage/culture container | A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 54987350702659 | GS1 | carton | 4 | In Commercial Distribution | |
| Package | 34987350702655 | GS1 | shelfbox | 25 | In Commercial Distribution | |
| Primary | 04987350702654 | GS1 |
Customer Contacts
- Phone
- 13032052510
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 600 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile