FDA UDI
In Commercial Distribution
🇺🇸 United States
Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B0
DI: 18051160302809
·
Model: CGSP8-B0
·
SPECTRUM MEDICAL SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B0
- Primary DI
- 18051160302809
- Version / Model
- CGSP8-B0
- Company Name
- SPECTRUM MEDICAL SRL
- Labeler DUNS
- 436188505
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-06
- Public Version
- 1
- Public Version Date
- 2024-08-14
- Public Version Status
- New
- Public Device Record Key
- f3fb99a5-ab08-4622-bd48-4b01b6494e67
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
- Yes
- 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 |
|---|---|---|---|---|
| 16163 | Cardioplegia solution administration kit | A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18051160302809 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213540 | 000 |