FDA UDI
In Commercial Distribution
🇺🇸 United States
FareTec PST
DI: B54122210370
·
Model: Military
·
FARETEC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FareTec PST
- Primary DI
- B54122210370
- Version / Model
- Military
- Catalog Number
- 2221037
- Company Name
- FARETEC, INC.
- Labeler DUNS
- 626802540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2022-12-28
- Public Version Status
- Update
- Public Device Record Key
- e2c71756-e43a-4ce8-a5ae-fc9538a5b98f
Device Description
FareTec PST, Military, Custom
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| FPO | Stretcher, Wheeled | General Hospital | 880.6910 | 2 |
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64999 | Stretcher all-terrain wheeled undercarriage | A non-powered, manually-operated (hand-pushed) undercarriage consisting of a heavy-duty frame with large wheels designed to accept a patient stretcher/board (not included) on its top and intended to facilitate transport of a recumbent patient by emergency medical services, primarily over difficult terrain inaccessible to conventional ambulance stretchers (e.g., off-road, mountain sites), typically to and from ambulances, emergency shelters, and mobile hospitals. It is constructed of sturdy materials, includes locks/clamps for securing the stretcher, and is foldable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B54122210370 | HIBCC |
Customer Contacts
- Phone
- 4403509510
- [email protected]