FDA UDI
In Commercial Distribution
🇺🇸 United States
PROBASICS
DI: 00815067072910
·
Model: PB6074RW
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROBASICS
- Primary DI
- 00815067072910
- Version / Model
- PB6074RW
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-20
- Public Version
- 2
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- 9faee7e2-ac0b-4e62-9ccb-a2ad822a5942
Device Description
3 Position Recliner - Rose 19x19.5, 250 WT Cap
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
- 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
- No
- 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 |
|---|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10790 | Cardiopulmonary rehabilitation chair, manual | A manually-operated device designed to support a cardiac/pulmonary patient in a seated position and to facilitate their placement in an optimal posture for rehabilitation and mobilization. It typically includes an adjustable headrest, back rest, and arms; it may have a design that permits easy patient monitoring. Some types permit limited indoor transportation and/or include a table for patient use (e.g., dining, writing) and safety belts. The device is widely used in acute care settings, and for short- and long-term rehabilitation; it is typically intended for patients with chronic cardiac diseases that benefit from being out of bed, such as those with congestive heart failure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815067072910 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]