Wells Johnson Infusion System (WIS) 20-6000-00

GUDID B458206000000

Wells Johnson Infusion System (WIS) 115-264VAC, 50/60Hz, 48W, specify single or dual head

The Wells Johnson Company

Bedside infusion pump, single-channel

• Primary Device ID: B458206000000
• NIH Device Record Key: 85ba0e32-35f3-4e10-8019-1c6fe74eb388
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wells Johnson Infusion System (WIS)
• Version Model Number: 20600000
• Catalog Number: 20-6000-00
• Company DUNS: 048931625
• Company Name: The Wells Johnson Company
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B458206000000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991437

FDA Product Code

• FRN: Pump, Infusion

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: 2023-07-24
• Device Publish Date: 2023-07-14

Devices Manufactured by The Wells Johnson Company

• B458208300000 - HVC3™: 2024-10-16 HVC3™ (High Volume Canister, 3L)
• B458201266000 - FISCHER (ALOUF): 2024-04-29 Cannula, Fischer (Alouf), specify length, diameter and handle/hub
• B458201360000 - INFILTRATION CANNULA SET, WIS (2): 2024-03-04 SET, CANNULA, INFILTRATION, WIS (2), contains: -Multi-Hole 6 13g x 25cm on dll (P/N: 20-1218-00) -Multi-Hole 6 14g x 17cm on dll
• B458201046020 - KHOURI CANNULA SET: 2024-01-31 Cannula Set, Khouri Cannula Set, contains: -Khouri Harvesting 12g x 20cm on dll (P/N: 20-1281-00) -Khouri Harvesting 12g x 25cm
• B458201281000 - KHOURI HARVESTING 12g: 2024-01-31 Cannula, Khouri Harvesting, 12g, specify length (20cm,25cm,30cm), on dll
• B458201284000 - KHOURI SPATULA 14g x 15cm: 2024-01-31 Cannula, Khouri Spatula, 14g x 15cm on dll
• B458201235000 - CUSTOM CANNULA: 2023-12-05 Cannula, Custom, specify custom tip style, length, diameter and handle/hub
• B458205061000 - Wells Johnson Elite Infiltrator/Aspirator: 2023-11-28 Wells Johnson Elite Infiltrator/Aspirator, 110-120VAC 50Hz, 115-120VAC 60Hz