PassPort MAIL-IN SYSTEM

Basic Information

• Brand Name: PassPort MAIL-IN SYSTEM
• Primary DI: 10732224720040
• Version / Model: EMS-052
• Catalog Number: EMS-052
• Company Name: SPS Medical Supply Corp.
• Labeler DUNS: 194877072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 52
• Record Status: Published
• Publish Date: 2016-11-15
• Public Version: 4
• Public Version Date: 2024-01-18
• Public Version Status: Update
• Public Device Record Key: e3b5acd9-5841-4a6f-9586-830d148632f8

Device Description

Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• 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
FRC	Indicator, biological sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50732224720048	GS1	box	4	In Commercial Distribution
Primary	10732224720040	GS1
Unit of Use	00732224720043	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Controlled room temperature per USP
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius