FDA UDI
In Commercial Distribution
🇺🇸 United States
AirDrive Caddie™
DI: 10841962111031
·
Model: RT-5100-S
·
Qfix
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AirDrive Caddie™
- Primary DI
- 10841962111031
- Version / Model
- RT-5100-S
- Catalog Number
- RT-5100-S
- Company Name
- Qfix
- Labeler DUNS
- 808875397
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-27
- Public Version
- 2
- Public Version Date
- 2023-12-11
- Public Version Status
- Update
- Public Device Record Key
- 93b97b78-e4f8-42c9-9fd8-e36a783c7700
Device Description
AirDrive Caddie™
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
- Yes
- 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 |
|---|---|---|---|---|
| FSA | Lift, Patient, Non-Ac-Powered | General Hospital | 880.5510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37160 | Patient transfer system, powered | A mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841962111031 | GS1 |
Customer Contacts
- Phone
- 610-268-0585
- [email protected]