FDA UDI
In Commercial Distribution
🇺🇸 United States
MICRO
DI: 08033178100830
·
Model: D732 27µ AD ART. FILTER + PURGE LINE
·
SORIN GROUP ITALIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MICRO
- Primary DI
- 08033178100830
- Version / Model
- D732 27µ AD ART. FILTER + PURGE LINE
- Company Name
- SORIN GROUP ITALIA SRL
- Labeler DUNS
- 442126587
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 530ce1ab-9646-41bb-9c61-393f9fd9dfbe
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 |
|---|---|---|---|---|
| DTM | Filter, blood, cardiopulmonary bypass, arterial line | Cardiovascular | 870.4260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33309 | Cardiopulmonary bypass system filter, arterial blood line | A sterile, porous device used in the arterial line of an extracorporeal circuit, during a cardiopulmonary bypass procedure, to trap and remove potentially harmful gaseous emboli, aggregated blood constituents, and particles greater than a specified size (e.g., 40 microns) to prevent them from flowing into the bloodstream and obstructing extracorporeal circulation. It is commonly referred to as a bubble trap and will typically be used for a specified length of time (e.g., 6 hours). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38033178100831 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 08033178100830 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K952270 | 000 |