FDA UDI
In Commercial Distribution
🇺🇸 United States
Lithotomy AirShuttle™
DI: 10841962111277
·
Model: RT-5100-05
·
Qfix
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lithotomy AirShuttle™
- Primary DI
- 10841962111277
- Version / Model
- RT-5100-05
- Catalog Number
- RT-5100-05
- Company Name
- Qfix
- Labeler DUNS
- 808875397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-28
- Public Version
- 3
- Public Version Date
- 2023-12-11
- Public Version Status
- Update
- Public Device Record Key
- d43ab054-df0c-4b43-bea1-6d43abfc6f35
Device Description
Lithotomy AirShuttle™
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | Radiology | 892.1200 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | Radiology | 892.5050 | 2 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| JAI | Couch, Radiation Therapy, Powered | Radiology | 892.5770 | 2 |
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
| FRZ | Device, Patient Transfer, Powered | General Hospital | 880.6775 | 2 |
| KPS | System, Tomography, Computed, Emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40536 | Patient lifting system stretcher | A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a lying (horizontal) position for transfer and (re)positioning. It is designed as an elongated framework with a solid or soft surface upon which the person to be lifted is placed and contained during the lifting process. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841962111277 | GS1 |
Customer Contacts
- Phone
- 610-268-0585
- [email protected]