FDA UDI
In Commercial Distribution
🇺🇸 United States
Level 1
DI: 30695085000321
·
Model: ES400-18
·
ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Level 1
- Primary DI
- 30695085000321
- Version / Model
- ES400-18
- Company Name
- ICU MEDICAL, INC.
- Labeler DUNS
- 118380146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-15
- Public Version
- 5
- Public Version Date
- 2025-04-16
- Public Version Status
- Update
- Public Device Record Key
- 2178f9b2-981c-4cb6-8e9a-b19d2fcfe6d5
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 |
|---|---|---|---|---|
| BZT | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS | Anesthesiology | 868.1920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35254 | General-purpose patient temperature probe, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10695085000327 | GS1 | BOX | 20 | In Commercial Distribution | |
| Primary | 30695085000321 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K854212 | 000 |