Spectrum, Inc.

Basic Information

• Brand Name: Spectrum, Inc.
• Primary DI: 00855495007405
• Version / Model: 985-03938-000
• Catalog Number: 75658-00003-00
• Company Name: SPECTRUM, INC.
• Labeler DUNS: 080458964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e51e3878-25ee-42d1-a408-07e258f05700

Device Description

Non-Sterile Heel/Elbow Protection Cushion

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: Yes
• MRI Safety: MR Safe
• 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
KIC	CUSHION, FLOTATION	Physical Medicine	890.3175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41571	Custom-made cushion	A soft pillow or pad that is specially designed for an individual to provide support, comfort, or assist the user to fulfill a functional requirement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10855495007402	GS1	Box	2	In Commercial Distribution
Primary	00855495007405	GS1
Package	20855495007409	GS1	shipper	24	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 3
• Email: [email protected]