CUSTOM HEALTHCARE SYSTEMS, INC.

Basic Information

• Brand Name: CUSTOM HEALTHCARE SYSTEMS, INC.
• Primary DI: 00811870033933
• Version / Model: B9-19530
• Company Name: Manus Medical, LLC
• Labeler DUNS: 800604196
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-11
• Public Version: 3
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 5a5daeea-ca22-4ec7-a35a-afeb73bfba66

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
LRO	General Surgery Tray	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46382	Peripheral anaesthesia single-administration set, non-medicated	A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20811870033937	GS1	N/A	10	In Commercial Distribution
Primary	00811870033933	GS1