FDA UDI
In Commercial Distribution
🇺🇸 United States
Mor-Medical New Era
DI: 00850010988320
·
Model: DNE-CCRT-10
·
Moroles Investments, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mor-Medical New Era
- Primary DI
- 00850010988320
- Version / Model
- DNE-CCRT-10
- Company Name
- Moroles Investments, LLC
- Labeler DUNS
- 045103307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-18
- Public Version
- 1
- Public Version Date
- 2024-07-26
- Public Version Status
- New
- Public Device Record Key
- 9715f51b-24d9-4054-9c0b-b0d0c869edfb
Device Description
Deluxe New Era Patented Infection Control Crash Cart with Pull Out Bins
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Anesthesiology | 868.6175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40596 | Electromechanical device/system transport trolley | A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850010988320 | GS1 |