FDA UDI
In Commercial Distribution
🇺🇸 United States
ICU Medical
DI: 00840619044121
·
Model: 41420-01
·
ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ICU Medical
- Primary DI
- 00840619044121
- Version / Model
- 41420-01
- Catalog Number
- 414200401
- Company Name
- ICU MEDICAL, INC.
- Labeler DUNS
- 118380146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-29
- Public Version
- 1
- Public Version Date
- 2021-09-06
- Public Version Status
- New
- Public Device Record Key
- 455d0974-d681-41ba-a668-312a017291d0
Device Description
Cooling Container, Iced Thermo
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
- 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 |
|---|---|---|---|---|
| 44833 | Blood stream indicator injector, mechanical | A device designed for accurate injection of an indicator solution (e.g., cooled saline, dye) into the blood stream that includes a mechanical mechanism used to inject the solution, in a closed loop, into a blood vessel through an indwelling catheter (e.g., Swan-Ganz cardiac catheter) mainly to assess heart blood flow and measure cardiac output. It may be used in conjunction with a densitometer or a thermodilution device to determine cardiac output. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840619044128 | GS1 | CS | 6 | In Commercial Distribution | |
| Primary | 00840619044121 | GS1 |
Customer Contacts
- Phone
- +1(866)829-9025
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K884318 | 000 |