FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756777544
·
Model: 81-041418
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756777544
- Version / Model
- 81-041418
- Catalog Number
- 81-041418
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-12
- Public Version
- 1
- Public Version Date
- 2021-07-20
- Public Version Status
- New
- Public Device Record Key
- 319304e7-788c-4fd5-abea-09459ed9c782
Device Description
Esophageal Stethoscope w/Temperature Sensor
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
- Yes
- 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
- No
- 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 | 50749756777549 | GS1 | Case | 100 | In Commercial Distribution | |
| Primary | 00749756777544 | GS1 | ||||
| Package | 30749756777545 | GS1 | Box | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]