FDA UDI
In Commercial Distribution
🇺🇸 United States
XTRA
DI: 08033178114332
·
Model: SEQUESTRATION SET X
·
SORIN GROUP ITALIA SRL
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- XTRA
- Primary DI
- 08033178114332
- Version / Model
- SEQUESTRATION SET X
- Company Name
- SORIN GROUP ITALIA SRL
- Labeler DUNS
- 442126587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-20
- Public Version
- 1
- Public Version Date
- 2024-12-30
- Public Version Status
- New
- Public Device Record Key
- 10a7a2d8-a7df-474f-aebb-e826ca1d6a06
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 |
|---|---|---|---|---|
| CAC | Apparatus, autotransfusion | Anesthesiology | 868.5830 | 2 |
| DTN | Reservoir, blood, cardiopulmonary bypass | Cardiovascular | 870.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44034 | Blood donor set, double-pack | An assembly of sterile devices intended to be used to collect whole blood from a donor and separate the red blood cells and plasma. It includes two containers (flexible bags) ? one with anticoagulation solution and/or preservatives for red blood cells, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the red blood cells and plasma are separated, via centrifugation, into separate containers and subsequently tested, stored, and infused from the containers when needed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38033178114333 | GS1 | BOX | 40 | In Commercial Distribution | |
| Package | 18033178114339 | GS1 | BOX | 8 | In Commercial Distribution | |
| Primary | 08033178114332 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241236 | 000 |