Immedia

Basic Information

• Brand Name: Immedia
• Primary DI: 05708012001507
• Version / Model: PediTurn Hard
• Catalog Number: IM99700
• Company Name: Etac Immedia A/S
• Labeler DUNS: 305519845
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-31
• Public Version: 1
• Public Version Date: 2022-11-08
• Public Version Status: New
• Public Device Record Key: 4bee21bd-c96b-4415-826f-3efd515b9852

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
IKX	AID, TRANSFER	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37164	Patient position turntable	A non-powered, manual device typically in the form of a rotating flat plate/disk intended to be positioned under a patient's buttocks or feet (when standing) to allow healthcare provider to pivot the patient for a change in position or direction, typically to facilitate proximal patient transfer (e.g., from bed to toilet); it has no lifting capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708012001507	GS1