FDA UDI
In Commercial Distribution
🇺🇸 United States
Salvaclip Safe
DI: 08436035353149
·
Model: SCF4165
·
MEDI CARE SYSTEM SLU
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Salvaclip Safe
- Primary DI
- 08436035353149
- Version / Model
- SCF4165
- Company Name
- MEDI CARE SYSTEM SLU
- Labeler DUNS
- 511139446
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-22
- Public Version
- 5
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- aff0b53a-9ba2-47c8-9610-a8b2d77d4110
Device Description
Vest with perineal to reposition the patient on wheel chair with security lock
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
- MR Unsafe
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| FMQ | Restraint, protective | General Hospital | 880.6760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13356 | Wheelchair/chair/stander occupant restraint/support | A rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08436035353408 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 08436035353149 | GS1 |
Customer Contacts
- Phone
- +34937570049
- [email protected]