Celerity PCC079

GUDID 50724995218589

Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilization cycle of a V-PRO Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology.

ALBERT BROWNE LIMITED

Chemical/physical sterilization process indicator

• Primary Device ID: 50724995218589
• NIH Device Record Key: 03f6286a-95e8-4b41-be4a-a36c292786db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celerity
• Version Model Number: PCC079
• Catalog Number: PCC079
• Company DUNS: 218172765
• Company Name: ALBERT BROWNE LIMITED
• Device Count: 200
• 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(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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• Phone: +1(800)548-4873
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995218584 [Unit of Use]
GS1	10724995218581 [Primary]
GS1	50724995218589 [Package]; Contains: 10724995218581; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213262

FDA Product Code

• QKM: A chemical vapor sterilization multivariable chemical indicator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-18
• Device Publish Date: 2022-08-10

On-Brand Devices [Celerity]

• 50724995172188: CELERITY 10 Chemical Indicator
• 10724995190665: The Celerity VH202 Adhesive Label is used with V-PRO Low Temperature Sterilizers and some cycles
• 50724995164749: The Celerity HP Chemical Indicator is used with V-PRO Low Temperature Sterilizers and some cycle
• 50724995164732: The Celerity HP Chemical Indicator is a validated Type 1 process indicator for vaporized hydroge
• 50724995218589: Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible,
• 50724995229547: Celerity Chemical Indicator for enspire 3000 CLCSPS employing S40 Sterilant.