FDA UDI
In Commercial Distribution
🇺🇸 United States
TurnAssist®
DI: G0648317270013971
·
Model: 831727001397
·
Walgreen Health Solutions, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- TurnAssist®
- Primary DI
- G0648317270013971
- Version / Model
- 831727001397
- Catalog Number
- 831727001397
- Company Name
- Walgreen Health Solutions, LLC
- Labeler DUNS
- 116685742
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-12-09
- Public Version
- 2
- Public Version Date
- 2023-09-20
- Public Version Status
- Update
- Public Device Record Key
- cd04c233-7acb-4d7c-b310-47bfd42bcf91
Device Description
TurnAssist® 30-degree Premium Positioning Wedge (pair), Freestanding Patient Positioner, 18-inch Wedge for Upper Torso,14-inch Wedge for Lower Torso. Size Large.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58878 | Freestanding patient positioner, reusable | A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | G0648317270013970 | HIBCC | ||||
| Primary | G0648317270013971 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 11 | Inch | |
| Width | 7.5 | Inch |