FDA UDI
In Commercial Distribution
🇺🇸 United States
CO-SET INJECTATE ICE BUCKET
DI: 00690103000078
·
Model: 93520
·
Edwards Lifesciences LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- CO-SET INJECTATE ICE BUCKET
- Primary DI
- 00690103000078
- Version / Model
- 93520
- Catalog Number
- 93520
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-16
- Public Version
- 1
- Public Version Date
- 2025-07-24
- Public Version Status
- New
- Public Device Record Key
- e1a9ff25-6994-4883-9487-c2339afc1b73
Device Description
CO-SET INJECTATE ICE BUCKET 6 PER CASE
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KRB | Probe, Thermodilution | Cardiovascular | 870.1915 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37340 | General-purpose patient temperature probe, reusable | A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50690103000073 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00690103000078 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K811399 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A COOL, DRY PLACE.