Affinity® Surface

Basic Information

• Brand Name: Affinity® Surface
• Primary DI: 00887761998353
• Version / Model: P3635A1
• Company Name: HILL-ROM, INC.
• Labeler DUNS: 004245668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 4
• Public Version Date: 2022-10-18
• Public Version Status: Update
• Public Device Record Key: 82eedd91-f4b6-4fd7-9db2-9d95902823a0

Device Description

Hospital Bed Surface

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: No
• Has Serial Number: No
• 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
KNC	TABLE, OBSTETRIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.4900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35183	Basic bed mattress	A large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887761998353	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]