FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756951180
·
Model: M2300-NC12
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756951180
- Version / Model
- M2300-NC12
- Catalog Number
- M2300-NC12
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-03
- Public Version
- 1
- Public Version Date
- 2021-08-11
- Public Version Status
- New
- Public Device Record Key
- 597c49ea-50d6-46d6-a369-2deea3bd246d
Device Description
NURSE CALL CORD
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KMI | MONITOR, BED PATIENT | General Hospital | 880.2400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41915 | Medical device service rail system | An assembly of devices and components designed to provide a secure method of fixing/mounting/organizing medical/non-medical devices being used in the vicinity of the patient for treatment/care and to provide services. It is typically be used in hospital wards, treatment rooms or intensive care units (ICU) where there is a demand for built-in amenities (e.g., electricity, medical gases, nurse call system and/or intercom systems). It is fixed to the wall or built onto the wall. The rail will have a preformed cross-section incorporating a safety design compatible to the clamps and holders to be used with the rail to provide the mounting method. It is typically supplied in prefabricated units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00749756951180 | GS1 |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]