DUAL DOT LABEL DDL-010

GUDID 50732224730719

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

SPS Medical Supply Corp.

Chemical/physical sterilization process indicator

• Primary Device ID: 50732224730719
• NIH Device Record Key: 565a84d3-6e2f-4071-9c19-1dd1fb883630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUAL DOT LABEL
• Version Model Number: DDL-010
• Catalog Number: DDL-010
• Company DUNS: 194877072
• Company Name: SPS Medical Supply Corp.
• Device Count: 800
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224730714 [Unit of Use]
GS1	10732224730711 [Primary]
GS1	50732224730719 [Package]; Contains: 10732224730711; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890763

FDA Product Code

• JOJ: Indicator, physical/chemical sterilization process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-19
• Device Publish Date: 2016-11-15

Devices Manufactured by SPS Medical Supply Corp.

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• 50732224720017 - PASSPORT MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720024 - PASSPORT MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720031 - PassPort MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720048 - PassPort MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720796 - PASSPORT PLUS MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
• 50732224720802 - PASSPORT PLUS MAIL-IN SYSTEM: 2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.