Batrik Vicoelastic Poly/Seat Cushion

Basic Information

• Brand Name: Batrik Vicoelastic Poly/Seat Cushion
• Primary DI: 00690521010055
• Version / Model: 81-005
• Catalog Number: 81-005
• Company Name: Batrik Medical Manufacturing Inc
• Labeler DUNS: 243880700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 1
• Public Version Date: 2020-10-05
• Public Version Status: New
• Public Device Record Key: 258dee60-43e6-484f-8239-51d0ef13ad78

Device Description

Blue Cloud Vicoelastic Poly/Seat 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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64493	Anti-fatigue floor mat	A pad designed to be stood on by healthcare staff to reduce fatigue associated with standing for prolonged periods (e.g., during procedures). It is designed to cushion the feet of the user and may include additional secondary features (e.g., non-slip, antimicrobial surface). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690521010055	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at ambient temperature and away from direct sunlight