XTRA
- Primary DI
- 38033178110809
- Brand
- XTRA
- Company
- SORIN GROUP ITALIA SRL
- Model
- PROCEDURE SET BX/225
- Published
- 2015-07-06
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| CAC | APPARATUS, AUTOTRANSFUSION |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | Anesthesiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K101586 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 38033178110809 | Package | GS1 | 3 | In Commercial Distribution |
| 08033178110808 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 38033178110809 | 38033178110809 | |
| 08033178110808 | 08033178110808 | 8033178110808 |
GMDN Terms#
| Term | Definition |
|---|---|
| Red blood cell-recovery autotransfusion system | An assembly of devices designed to collect and process blood lost by a patient to obtain red blood cells for subsequent reinfusion into the same patient (i.e., autotransfusion). It typically includes a disposable suction system to collect blood from the surgical field, a reservoir to store the blood, a spinning processing chamber (e.g., a centrifuge) to separate waste (e.g., clotting factors, debris) and wash the red blood cells with saline, particulate microfilters, and a reinfusion bag that stores the red blood cells in saline. The system is used mainly during surgical procedures to minimize allogeneic blood use, but may be used postoperatively and in emergency or intensive care units. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 442126587
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 08033178102933 | DHF | 02 HEMOCONCENTRATOR | 2015-07-15 | |
| 08033178102940 | DHF | 06 HEMOCONCENTRATOR | 2015-07-15 | |
| 08033178109062 | CSC 14 | CSC14 + PURGE LINE | 2015-07-10 | |
| 08033178112253 | INSPIRE | 6M | 2015-05-13 | |
| 08033178112277 | INSPIRE | 6F M | 2015-05-13 | |
| 08033178112284 | INSPIRE | 8F M | 2015-05-13 | |
| 08033178112291 | INSPIRE | HVR | 2015-05-13 | |
| 08033178112307 | INSPIRE | HVR DUAL | 2015-05-13 | |
| 08033178112352 | INSPIRE | 6 PH.I.S.I.O. | 2015-05-13 | |
| 08033178112369 | INSPIRE | 8 PH.I.S.I.O. | 2015-05-13 | |
| 08033178112376 | INSPIRE | 6F PH.I.S.I.O. | 2015-05-13 | |
| 08033178112383 | INSPIRE | 8F PH.I.S.I.O. | 2015-05-13 | |
| 08033178112390 | INSPIRE | 6 DUAL PH.I.S.I.O. | 2015-05-13 | |
| 08033178112406 | INSPIRE | 8 DUAL PH.I.S.I.O. | 2015-05-13 | |
| 08033178112413 | INSPIRE | 6F DUAL PH.I.S.I.O. | 2015-05-13 | |
| 08033178112420 | INSPIRE | 8F DUAL PH.I.S.I.O. | 2015-05-13 | |
| 08033178113014 | INSPIRE | SVR 1200 | 2017-03-29 | |
| 08033178113182 | INSPIRE | 7 M | 2019-08-28 | |
| 08033178113212 | INSPIRE | 7 | 2019-08-28 | |
| 08033178113236 | INSPIRE | 7 DUAL | 2019-08-28 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 14026704937230 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2026-05-08 |
| 14026704937308 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2026-05-08 |
| 14026704937315 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2026-05-08 |
| 14026704912206 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2025-09-17 |
| 14026704912213 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2025-09-17 |
| 14026704911797 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2025-09-04 |
| 14026704911803 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2025-09-04 |
| 14026704911865 | PLEUR-EVAC | TELEFLEX INCORPORATED | CAC | 2025-04-29 |
| 08033178113700 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113717 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113724 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113731 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113748 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113755 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113762 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113922 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113939 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113946 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113953 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113960 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113977 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113984 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178113991 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178114004 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178114011 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178114028 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178114035 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178114042 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178114059 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |
| 08033178114066 | XTRA | SORIN GROUP ITALIA SRL | CAC | 2024-12-20 |