FDA UDI
In Commercial Distribution
🇺🇸 United States
AUTOTRANSFUSION ACCESSORIES
DI: 08033178105422
·
Model: BT074 COD.039
·
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
- 08033178105422
- Version / Model
- BT074 COD.039
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 79be12db-f6fa-4f2e-a543-00ada7df8a41
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 |
|---|---|---|---|---|
| DTN | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42924 | Blood autotransfusion system tubing | A sterile length of flexible tube, typically made of synthetic polymer material(s), intended to be used in a blood autotransfusion system typically as an extension to channel blood between the bellows and the autotransfusion bag. The tubing may be used to maintain a closed-circuit during blood collection and reinfusion. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18033178105429 | GS1 | BOX | 20 | In Commercial Distribution | |
| Primary | 08033178105422 | GS1 | ||||
| Package | 38033178105423 | GS1 | BOX | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K884872 | 000 |