FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Quantum ®
DI: 05020583210233
·
Model: 21023
·
TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Quantum ®
- Primary DI
- 05020583210233
- Version / Model
- 21023
- 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
- 7
- Public Version Date
- 2023-07-24
- Public Version Status
- Update
- Public Device Record Key
- 2af0a794-7369-490a-9263-2ade2167a598
- Distribution End Date
- 2020-07-01
Device Description
Quantum System Cell Expansion Set and Accessories, Waste Bag 4L, Accessory Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KJF | SYSTEM, SUSPENSION, CELL CULTURE | Hematology | 864.2240 | 1 |
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 |
|---|---|---|---|---|---|---|
| Primary | 05020583210233 | GS1 | ||||
| Package | 35020583210234 | GS1 | 10 | Not in Commercial Distribution | 2020-07-01 |
Customer Contacts
- Phone
- +1(877)339-4228
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from rain
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 40 Degrees Celsius