FDA UDI
In Commercial Distribution
🇺🇸 United States
XpeditionTM Powered Stair Chair (mid configuration)
DI: 07613327581621
·
Model: 6257
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XpeditionTM Powered Stair Chair (mid configuration)
- Primary DI
- 07613327581621
- Version / Model
- 6257
- Catalog Number
- 625700000000
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 078470558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-26
- Public Version
- 1
- Public Version Date
- 2023-05-04
- Public Version Status
- New
- Public Device Record Key
- 320d7129-e49a-4653-960a-74569732e293
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ILK | Transport, patient, powered | Physical Medicine | 890.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16906 | Stair chair | A device in which a disabled or infirm person sits in order to be manually transported by attendants/nursing staff up or down a flight of stairs. The device is typically constructed with hand bars, locking/opening bars or straps, and reinforced legs, with or without wheels, to facilitate patient transport on stairs. The device is typically used in emergency situations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327581621 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222818 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 149 Degrees Fahrenheit
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 149 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal