FDA UDI
In Commercial Distribution
🇺🇸 United States
Hill-Rom
DI: 00841965100950
·
Model: Compella
·
Tridien Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hill-Rom
- Primary DI
- 00841965100950
- Version / Model
- Compella
- Catalog Number
- 23SM-CHE-ENM-G
- Company Name
- Tridien Medical
- Labeler DUNS
- 625060962
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 15f4a2b9-a3ce-44ed-a8b8-f1701bd7eccb
Device Description
Controller CAP HV ENG MKS G
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 |
|---|---|---|---|---|
| IKZ | Bed, Patient Rotation, Powered | Physical Medicine | 890.5225 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34869 | Rotation bed, electric | A mains electricity (AC-powered) bed that provides automated rotation of the patient in a circular framework using electric power. It is used for patients with severe fractures and/or spinal cord injuries to provide an essential periodic change (i.e., rotation) of the patient's body position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841965100950 | GS1 |
Customer Contacts
- Phone
- 1 800 474 4225
- [email protected]