DUAL DOT LABEL

Basic Information

• Brand Name: DUAL DOT LABEL
• Primary DI: 10732224730711
• Version / Model: DDL-010
• Catalog Number: DDL-010
• Company Name: SPS Medical Supply Corp.
• Labeler DUNS: 194877072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 800
• Record Status: Published
• Publish Date: 2016-11-15
• Public Version: 4
• Public Version Date: 2023-11-20
• Public Version Status: Update
• Public Device Record Key: 565a84d3-6e2f-4071-9c19-1dd1fb883630

Device Description

Labels that provide a distinct color change when exposed to the appropriate sterilization process

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: 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
JOJ	Indicator, physical/chemical sterilization process	General Hospital	880.2800	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
Package	50732224730719	GS1	box	10	In Commercial Distribution
Primary	10732224730711	GS1
Unit of Use	00732224730714	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K890763	000

Storage Conditions

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