CASE MEDICAL

Basic Information

• Brand Name: CASE MEDICAL
• Primary DI: 00653159012624
• Version / Model: SCLH2023-5
• Catalog Number: SCLH2023-5
• Company Name: Case Medical Inc.
• Labeler DUNS: 053057972
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2023-08-15
• Public Version: 2
• Public Version Date: 2023-10-20
• Public Version Status: Update
• Public Device Record Key: 3b31614c-cadd-4619-96ec-628f0a7b357d

Device Description

CHEMICAL INDICATOR LOAD CARDS H2O2 / STERRAD STERILIZATION LARGE (500 PK)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00653159012624	GS1
Unit of Use	10653159012621	GS1