FDA UDI
In Commercial Distribution
🇺🇸 United States
PRIMO
DI: 00840216127562
·
Model: AFTMATT
·
Asp Global, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PRIMO
- Primary DI
- 00840216127562
- Version / Model
- AFTMATT
- Company Name
- Asp Global, LLC
- Labeler DUNS
- 080361159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-12
- Public Version
- 1
- Public Version Date
- 2024-08-20
- Public Version Status
- New
- Public Device Record Key
- 90d3f904-0961-44ab-8d34-f2fd80b7ce20
Device Description
MATTRESS, PRIMO AIRFLOAT AIR TRANSFER, 39"X78", UNINFLATED, 1EA/BG, 10EA/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66835 | Inflatable patient transfer sliding mattress, single-use | An inflatable device designed to: 1) support a recumbent patient on a bed or table; and 2) assist healthcare professionals in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another using sliding techniques; some types may additionally be designed to provide skin protection to prevent pressure sores and/or support a patient in a specific position (e.g., Trendelenburg). It includes patient straps, handles for transfer, air hose inlets, and requires a pump (not included) for inflation; it is not intended for patient lifting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20840216127566 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00840216127562 | GS1 |