FDA UDI
In Commercial Distribution
🇺🇸 United States
Progressa+ surface
DI: 00887761967113
·
Model: P7540A0101000
·
Hill-Rom de México, S. de R.L. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Progressa+ surface
- Primary DI
- 00887761967113
- Version / Model
- P7540A0101000
- Company Name
- Hill-Rom de México, S. de R.L. de C.V.
- Labeler DUNS
- 813030004
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-15
- Public Version
- 1
- Public Version Date
- 2024-05-23
- Public Version Status
- New
- Public Device Record Key
- 87508e07-71cf-4087-8891-7f9555cd4bb4
Device Description
Progressa+ Mattress, Narrow-Advanced Articulation-Therapy-Alternating low pressure
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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| IOQ | BED, FLOTATION THERAPY, POWERED | Physical Medicine | 890.5170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47478 | Alternating-pressure bed mattress overlay system | An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887761967113 | GS1 |
Customer Contacts
- Phone
- +1(800)445-3730
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .5 – 1.06 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 140 Degrees Fahrenheit