FDA UDI
In Commercial Distribution
🇺🇸 United States
INTERCEPT Blood System for Cryoprecipitation
DI: 18717953197013
·
Model: INT3230
·
CERUS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- INTERCEPT Blood System for Cryoprecipitation
- Primary DI
- 18717953197013
- Version / Model
- INT3230
- Company Name
- CERUS CORPORATION
- Labeler DUNS
- 858999485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2021-03-22
- Public Version
- 1
- Public Version Date
- 2021-03-30
- Public Version Status
- New
- Public Device Record Key
- 75cf47e3-e85e-40f1-acf8-92a5613ff82f
Device Description
INTERCEPT Blood System for Cryoprecipitation
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| PJF | Illuminator System For Blood Products | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16752 | Blood washing/centrifugation bag | A flexible container intended to be used to facilitate blood processing via blood washing and/or centrifugation (e.g., cryoprecipitation) to achieve separation of blood components [e.g., red blood cells (RBCs), platelets, plasma], typically to generate a blood product from autologous or donor blood for procedural (e.g., surgical haemostasis) or transfusion applications [e.g., fibrinogen rich cryoprecipitate]. It is additionally intended to be used as a blood storage bag, and is made of flexible durable materials that withstand centrifugation and freezing/thawing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38717953197017 | GS1 | foil pouch | 8 | In Commercial Distribution | |
| Primary | 18717953197013 | GS1 | ||||
| Unit of Use | 08717953197016 | GS1 |
Customer Contacts
- Phone
- 1-855-835-3523
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 26 Degrees Celsius