FDA UDI
In Commercial Distribution
🇺🇸 United States
Everest & Jennings
DI: M36890H35061J1
·
Model: 90H35061J
·
GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Everest & Jennings
- Primary DI
- M36890H35061J1
- Version / Model
- 90H35061J
- Catalog Number
- 90H35061J
- Company Name
- GF HEALTH PRODUCTS, INC.
- Labeler DUNS
- 132016168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-04
- Public Version
- 1
- Public Version Date
- 2020-12-14
- Public Version Status
- New
- Public Device Record Key
- 3056b038-362c-4ba3-890b-327cba6f63b0
Device Description
Rehab Shower Commode Chair Back Upholstery Kit 16" & 19"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| INB | Attachment, Commode, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36254 | Wheelchair back rest | A padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M36890H35061J1 | HIBCC |
Customer Contacts
- Phone
- 770-368-4700
- [email protected]