FDA UDI
In Commercial Distribution
🇺🇸 United States
NP Adjust™ Mattress
DI: 00845699008230
·
Model: NP Adjust
·
SIZEWISE RENTALS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NP Adjust™ Mattress
- Primary DI
- 00845699008230
- Version / Model
- NP Adjust
- Company Name
- SIZEWISE RENTALS, L.L.C.
- Labeler DUNS
- 967025602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-16
- Public Version
- 1
- Public Version Date
- 2023-05-24
- Public Version Status
- New
- Public Device Record Key
- 82c86d96-e0a1-484d-a5bc-4702881b9fd6
Device Description
NP Adjust Mattress
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered | General Hospital | 880.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35183 | Basic bed mattress | A large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845699008230 | GS1 |