Wipe Down Body Wedge Set - Standard

Basic Information

• Brand Name: Wipe Down Body Wedge Set - Standard
• Primary DI: 00810006680065
• Version / Model: BPW11
• Catalog Number: BPW11
• Company Name: PRIMO INC
• Labeler DUNS: 958758146
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-20
• Public Version: 2
• Public Version Date: 2021-07-27
• Public Version Status: Update
• Public Device Record Key: f692695c-ffd1-48ce-b3ed-cc0dd5549670
• Distribution End Date: 2021-07-01

Device Description

Standard Wipe Down Body Wedge Set (2 each - Short)

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: 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
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
Package	10810006680062	GS1	CASE	11	Not in Commercial Distribution	2021-07-01
Primary	00810006680065	GS1