FDA UDI
In Commercial Distribution
🇺🇸 United States
ThevoVital FR 308 lbs, Full size 54x75”, jersey
DI: 04034089060118
·
Model: 9800628830004
·
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ThevoVital FR 308 lbs, Full size 54x75”, jersey
- Primary DI
- 04034089060118
- Version / Model
- 9800628830004
- Company Name
- Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
- Labeler DUNS
- 317356343
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-13
- Public Version
- 1
- Public Version Date
- 2022-07-21
- Public Version Status
- New
- Public Device Record Key
- ebac02e1-d4b2-44a3-a610-b61b38286afb
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
- 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 |
|---|---|---|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered | General Hospital | 880.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47520 | Orthopaedic bed mattress | A large, durable, fabric case filled with a combination of layered resilient materials (e.g., foam rubber and gel) designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and to promote therapeutic postures in users suffering back maladies (e.g., spinal column compression, back pain) through the homogenous distribution of body weight. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04034089060118 | GS1 |