FDA UDI
In Commercial Distribution
🇺🇸 United States
Binder Lift
DI: 00860012552184
·
Model: BT-FBX5-BL
·
We Stitch Stuff, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Binder Lift
- Primary DI
- 00860012552184
- Version / Model
- BT-FBX5-BL
- Catalog Number
- BT-FBX5-BL
- Company Name
- We Stitch Stuff, LLC
- Labeler DUNS
- 124463328
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-08
- Public Version
- 1
- Public Version Date
- 2024-11-18
- Public Version Status
- New
- Public Device Record Key
- cdae8464-45b3-4839-9320-6f55b64dd61f
Device Description
Binder Transfer Ferno X1 & X2 Bundle (Sheet/Transfer-aid with set of 8 anchors)
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66996 | Patient transfer/turning sheet, reusable | A manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012552184 | GS1 |
Customer Contacts
- Phone
- 605-412-8312
- [email protected]
- Phone
- 855-293-5438
- [email protected]