FDA UDI
In Commercial Distribution
🇺🇸 United States
Starboard Temperature Probes
DI: 00850933007047
·
Model: 40018-ES
·
STARBOARD MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Starboard Temperature Probes
- Primary DI
- 00850933007047
- Version / Model
- 40018-ES
- Catalog Number
- 40018-ES
- Company Name
- STARBOARD MEDICAL, INC.
- Labeler DUNS
- 012983893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e7f8a3a0-f82b-4489-9ca4-dd4ad8632bd0
Device Description
Esophageal Stethoscope with 400 Series Temperature Sensor, 18 Fr.
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
- Yes
- 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 |
|---|---|---|---|---|
| 44120 | Electronic oesophageal stethoscope, single-use | An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850933007044 | GS1 | Inner Pack | 30 | In Commercial Distribution | |
| Primary | 00850933007047 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111050 | 000 |