FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DMI
DI: 00041298019824
·
Model: 552-1982-0000
·
D-M-S HOLDINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DMI
- Primary DI
- 00041298019824
- Version / Model
- 552-1982-0000
- Catalog Number
- 552-1982-0000
- Company Name
- D-M-S HOLDINGS, INC.
- Labeler DUNS
- 062028220
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2023-05-18
- Public Version Status
- Update
- Public Device Record Key
- 61293738-aa6a-4af2-ba25-c3b7988f6c25
- Distribution End Date
- 2023-05-17
Device Description
PRESSURE PAD ALTERNATING ONLY 32 X 72 IN INFLATED
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
- No
- 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 |
|---|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | General Hospital | 880.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44192 | Alternating-pressure chair cushion, single-use | A pad intended to be placed on the seat of a chair and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's buttocks-chair contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10041298019821 | GS1 | Master Carton | 10 | Not in Commercial Distribution | 2023-05-17 |
| Primary | 00041298019824 | GS1 |