FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756399289
·
Model: PH81-080416
·
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
- 00749756399289
- Version / Model
- PH81-080416
- Catalog Number
- PH81-080416
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-23
- Public Version
- 1
- Public Version Date
- 2025-07-31
- Public Version Status
- New
- Public Device Record Key
- 716df6eb-2509-457a-8c58-9639c1d62170
Device Description
Foley Catheter with 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
- MR Conditional
- 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 |
|---|---|---|---|---|
| EYC | CATHETER, UPPER URINARY TRACT | Gastroenterology, Urology | 876.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46629 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50749756399284 | GS1 | CA | 2 | In Commercial Distribution | |
| Package | 30749756399280 | GS1 | BX | 25 | In Commercial Distribution | |
| Primary | 00749756399289 | GS1 |
Customer Contacts
- Phone
- +1(865)938-7828
- [email protected]