R82

Basic Information

• Brand Name: R82
• Primary DI: 05707292578099
• Version / Model: Orca ONE SIZE
• Catalog Number: 87550
• Company Name: R82 A/S
• Labeler DUNS: 308022169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-02
• Public Version: 1
• Public Version Date: 2023-08-10
• Public Version Status: New
• Public Device Record Key: 191d9754-e220-4050-bb14-52e24983a618

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: Yes
• Has Lot/Batch Number: No
• 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
ILS	ADAPTOR, HYGIENE	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13088	Portable reclining bathtub	A bathing (washing) receptacle designed to be easily moved (e.g., it may be readily dismantled and packed for transport). It is typically filled with warm water to accommodate the occupant's full body for bathing in a seated or reclined position. The device is typically used in settings where there is no access to conventional bathing facilities (e.g., field military hospitals, isolated dwellings).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05707292578099	GS1