FDA UDI
In Commercial Distribution
🇺🇸 United States
The Völkner® Turning System
DI: 00853360007079
·
Model: PANDA III 54" Bariatric Mattress Replacement
·
JAMES CONSOLIDATED, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Völkner® Turning System
- Primary DI
- 00853360007079
- Version / Model
- PANDA III 54" Bariatric Mattress Replacement
- Company Name
- JAMES CONSOLIDATED, INC.
- Labeler DUNS
- 183085083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-18
- Public Version
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 19c38ee5-96e0-496f-b405-d129804280a2
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | General Hospital | 880.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36688 | Alternating-pressure pump | An electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient. | No | Active |
| 17593 | Low-air-loss bed | A mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853360007079 | GS1 |