FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Surge Cardiovascular
DI: 00817278011757
·
Model: SUC-0840
·
Alliant Enterprises, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Surge Cardiovascular
- Primary DI
- 00817278011757
- Version / Model
- SUC-0840
- Catalog Number
- SUC-0840
- Company Name
- Alliant Enterprises, LLC
- Labeler DUNS
- 121170653
- Distribution Status
- Not 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
- c4769382-490a-4ad2-ab6e-18d9f625099e
- Distribution End Date
- 2018-03-27
Device Description
Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length, 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 |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817278011751 | GS1 | Case | 4 | Not in Commercial Distribution | 2018-03-27 |
| Package | 10817278011754 | GS1 | Inner Bag | 25 | Not in Commercial Distribution | 2018-03-27 |
| Primary | 00817278011757 | GS1 |