ENHLDLTR1

GUDID 00724995218126

Leak Test Hose Kit, Richard Wolfis used with the enspire 300 Series Automated Endoscope Reprocessor

STERIS CORPORATION

Luminal device flushing tubing set, reusable

• Primary Device ID: 00724995218126
• NIH Device Record Key: 8f21b3d0-f484-429d-95b0-6b14a1e147a6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: enspire 300 Leak Test
• Catalog Number: ENHLDLTR1
• Company DUNS: 868205779
• Company Name: STERIS CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995218126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230560

FDA Product Code

• MED: Sterilant, medical devices

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: 2024-04-25
• Device Publish Date: 2024-04-17

Devices Manufactured by STERIS CORPORATION

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• 00724995203214 - HarmonyAIR: 2025-01-28 HarmonyAIR E-Series High Density Dual Light, Dual Flat Panel Monitor is used with the HarmonyAIR E-Series Lighting System.
• 10724995231504 - CELERITY: 2025-01-21 Celerity HP Indicator Tape
• 00724995222017 - NA: 2024-12-03 Foot Extension with Siderail Locks, Velcro without Pad is used with the 7000 Series Surgical Table.
• 00724995222024 - NA: 2024-12-03 Foot Extension with Siderail Locks, Velcro with 2-inch TLT Pad is used with the 7000 Series Surgical Tables.
• 00724995222048 - NA: 2024-12-03 Bariatric Foot Extension withSiderail Locks, Velcro with 2-inch TLT Pad is used with the 7000 Series Surgical Table.
• 00724995222260 - NA: 2024-12-03 2-inch TLT Pad, Velcro, Foot Extension, is used with the 7000 Series Surgical Tables.
• 00724995222277 - NA: 2024-12-03 3-inch TLT Pad, Velcro, Foot Extension, is used with the 7000 Series Surgical Tables.