COMFOR CERVICAL PILLOW COVER

Basic Information

• Brand Name: COMFOR CERVICAL PILLOW COVER
• Primary DI: 00610570027286
• Version / Model: 08148715
• Company Name: Bird & Cronin, LLC
• Labeler DUNS: 045975349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-20
• Public Version: 1
• Public Version Date: 2022-08-29
• Public Version Status: New
• Public Device Record Key: d4e69012-66cf-4444-b71e-fb3491b0d28b

Device Characteristics

• Single Use: Yes
• 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
IQK	Orthosis, Cervical	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41573	Cervical spine cushion	A soft pillow or pad used to provide support and comfort to the user's neck, often during the treatment and/or prevention of musculoskeletal disorders or injuries. The device may be used to alleviate pressure on the neck and spinal cord while the user is sitting, lying, or standing. This device may function as a cushion under the neck when the user is supine, or it may be placed, even secured, around the user's neck to help support the head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00610570027286	GS1