FDA UDI
In Commercial Distribution
🇺🇸 United States
PROCARE
DI: 00888912038119
·
Model: 79-91000
·
DJO, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROCARE
- Primary DI
- 00888912038119
- Version / Model
- 79-91000
- Company Name
- DJO, LLC
- Labeler DUNS
- 081840873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-15
- Public Version
- 1
- Public Version Date
- 2022-09-23
- Public Version Status
- New
- Public Device Record Key
- c9cfbffa-2b5b-4767-a2cb-2a8bdf822a8e
Device Description
GAIT BELT,UNIVERSAL
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| FMQ | Restraint, protective | General Hospital | 880.6760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40538 | Manual patient lifting belt/harness | A device used to assist healthcare professionals or attending persons to physically move and lift a patient or a person with a disability (e.g., from the floor to a bed). The device is typically made strong textile materials (e.g., nylon or canvas) consisting of belts/harnesses. The device will typically require two persons to safely perform the lift. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888912038119 | GS1 |