FDA UDI
In Commercial Distribution
🇺🇸 United States
SPR Plus
DI: 07613327175042
·
Model: 2790
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SPR Plus
- Primary DI
- 07613327175042
- Version / Model
- 2790
- Catalog Number
- 2790-100-000
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 078470558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e30be6fa-8950-45e6-b184-1c8f8e3da909
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IOQ | BED, FLOTATION THERAPY, POWERED | Physical Medicine | 890.5170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 57613327175047 | GS1 | case | 6 | In Commercial Distribution | |
| Primary | 07613327175042 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity