FDA UDI
In Commercial Distribution
🇺🇸 United States
Regard™
DI: 00326053120275
·
Model: SLIDEREG-BARI
·
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Regard™
- Primary DI
- 00326053120275
- Version / Model
- SLIDEREG-BARI
- Catalog Number
- SLIDEREG-BARI
- Company Name
- RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
- Labeler DUNS
- 134472476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-30
- Public Version
- 1
- Public Version Date
- 2023-07-10
- Public Version Status
- New
- Public Device Record Key
- bd25982e-f9eb-426f-8c36-b2b07f02fb89
Device Description
Lateral Transfer Tube-Disposable 58X48
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37163 | Patient transfer sliding mat | A manual device typically in the form of an open roll mat or flat sheet designed to be used by healthcare professionals to assist in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the patient. It is typically designed using low-friction artificial fibres and intended to be slid under the patient who is then gently pushed by attending staff to glide across the surface of the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10326053120272 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00326053120275 | GS1 | ||||
| Package | 20326053120279 | GS1 | 5 | In Commercial Distribution |