FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTOTRANSFUSION ACCESSORIES
DI: 08033178105477
·
Model: COD. 131E
·
SORIN GROUP ITALIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AUTOTRANSFUSION ACCESSORIES
- Primary DI
- 08033178105477
- Version / Model
- COD. 131E
- Company Name
- SORIN GROUP ITALIA SRL
- Labeler DUNS
- 442126587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-15
- Public Version
- 4
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 9db66232-c078-491e-94c0-349ec308c527
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 |
|---|---|---|---|---|
| DWF | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46721 | Disposable vacuum tubing | A sterile length of flexible tube intended to be used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of malleable synthetic polymer material(s) (e.g., plastic, silicone) and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required (e.g., for an autologous blood transfusion system). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38033178105478 | GS1 | BOX | 50 | In Commercial Distribution | |
| Package | 18033178105474 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 08033178105477 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K872159 | 000 |