FDA UDI
In Commercial Distribution
🇺🇸 United States
RED LEAF
DI: 06974442051033
·
Model: CC-01 Adult
·
Jiangsu Rixin Medical Equipment Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RED LEAF
- Primary DI
- 06974442051033
- Version / Model
- CC-01 Adult
- Company Name
- Jiangsu Rixin Medical Equipment Co.,Ltd
- Labeler DUNS
- 547051297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-22
- Public Version
- 2
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 8f7a011c-5912-4816-a641-8a6ec3d0b095
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CCX | Support, Patient Position | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45258 | Extrication collar, reusable | A rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974442051033 | GS1 |