DeRoyal
- Primary DI
- 30749756045774
- Brand
- DeRoyal
- Company
- DEROYAL INDUSTRIES, INC.
- Model
- 81-080414
- Device description
- Foley Catheter with Temperature Sensor
- Published
- 2016-09-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| EYC | CATHETER, UPPER URINARY TRACT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EYC | Catheter, Upper Urinary Tract | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 30749756045774 | Package | GS1 | 25 | In Commercial Distribution |
| 50749756045778 | Package | GS1 | 50 | In Commercial Distribution |
| 00749756045773 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 30749756045774 | 30749756045774 | | |
| 50749756045778 | 50749756045778 | | |
| 00749756045773 | 00749756045773 | 749756045773 | 0749756045773 |
GMDN Terms
| Term | Definition |
|---|
| Temperature-monitoring indwelling urethral drainage catheter | A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as a long-term indwelling device for continuous urinary drainage and simultaneous monitoring of core body temperature through its integral temperature sensor, typically during or after surgery or in the presence of obstruction or paralysis. It may have a bent tip (coude) for negotiation of the prostatic curve and is typically made of silicone. It is inserted by trained staff and commonly known as a Foley catheter. This is a single-use device. |
Regulatory Flags
- DUNS number
- 096372255
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 50749756399277 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2025-07-23 |
| 50749756399284 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2025-07-23 |
| 50749756399291 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2025-07-23 |
| 50749756983995 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2021-05-07 |
| 50749756984008 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2021-05-07 |
| 50749756984015 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2021-05-07 |
| 70885403251315 | N/A | Carefusion Finland 320 Oy | EYC | 2016-09-14 |
| 70885403251322 | N/A | Carefusion Finland 320 Oy | EYC | 2016-09-14 |
| 70885403251650 | N/A | Carefusion Finland 320 Oy | EYC | 2016-09-14 |
| 30749756045743 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756045754 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756045767 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756045781 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756045798 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756045804 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756140114 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756140121 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756140138 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756596652 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756596665 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756596676 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756712267 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756712270 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756712281 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756712294 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 30749756712300 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756712311 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
| 50749756824533 | DeRoyal | DEROYAL INDUSTRIES, INC. | EYC | 2016-09-12 |
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