FDA UDI
In Commercial Distribution
🇺🇸 United States
Surge Cardiovascular
DI: 00817278011269
·
Model: SSD-100A
·
Alliant Enterprises, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Surge Cardiovascular
- Primary DI
- 00817278011269
- Version / Model
- SSD-100A
- Catalog Number
- SSD-100A
- Company Name
- Alliant Enterprises, LLC
- Labeler DUNS
- 121170653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-11-02
- Public Version Status
- Update
- Public Device Record Key
- 19295e5a-91a8-4bd8-bb96-0022446e6093
Device Description
Suction Safety Device, Non-Sterile
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 17581 | Cardiopulmonary bypass system valve, unidirectional flow/pressure control | A sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817278011266 | GS1 | Case | 4 | Not in Commercial Distribution | 2018-03-27 |
| Package | 00817278011917 | GS1 | Inner Bag | 25 | Not in Commercial Distribution | 2018-03-27 |
| Primary | 00817278011269 | GS1 |