Domico Med-Device

Basic Information

• Brand Name: Domico Med-Device
• Primary DI: 00861001002659
• Version / Model: 9121
• Company Name: DOMICO MED-DEVICE, LLC
• Labeler DUNS: 081253414
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-19
• Public Version: 1
• Public Version Date: 2019-12-27
• Public Version Status: New
• Public Device Record Key: 6514d631-c67f-47e0-ab80-4f175f7e38ca

Device Description

Universal Table Pad Cover

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35181	Waterproof bed mattress cover, single-use	A device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. This is a single-patient device intended to be used for a limited time, without laundering, until considered inappropriate for further use and then discarded (e.g., incinerated).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10861001002656	GS1		4	In Commercial Distribution
Primary	00861001002659	GS1