Custom Healthcare Systems Inc.

Basic Information

• Brand Name: Custom Healthcare Systems Inc.
• Primary DI: 00811870032172
• Version / Model: CDWS-19145
• Company Name: Manus Medical, LLC
• Labeler DUNS: 800604196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-25
• Public Version: 2
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 3c841fd3-e615-4d70-afff-2e941245ef02

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OEZ	Cardiovascular Procedure Kit	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47560	Medical gas pipeline system pressure reduction manifold	A device that is typically a component of a medical gas pipeline system designed to reduce high incoming pressure from a gas supply (e.g., bank of cylinders or tank) to an operational pressure safe for patients and laboratory devices. It is typically composed of pressure regulators, valves, and electrical pressure switches and may be designed to decrease the incoming gas pressure to an intermediate and then operational level. It may automatically and/or manually change to a reserve compressed gas supply, sometimes indicated by integral alarms, when the gas pressure in the primary supply becomes depleted. It is normal for a separate manifold to be used with each gas type.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811870032176	GS1		25	In Commercial Distribution
Primary	00811870032172	GS1