FUJIFILM medwork VAL1-F1-100

GUDID 04044503035158

FUJIFILM medwork GmbH

Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use

• Primary Device ID: 04044503035158
• NIH Device Record Key: 9e98890a-d8d4-4d4b-a2ef-58539603d73c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUJIFILM medwork
• Version Model Number: FROG VAL1-F1-100
• Catalog Number: VAL1-F1-100
• Company DUNS: 330797395
• Company Name: FUJIFILM medwork GmbH
• Device Count: 100
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx
• Phone: 800 385 4666
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04044503035158 [Primary]
GS1	14044503035155 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221264

FDA Product Code

• ODC: Endoscope Channel Accessory

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: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [FUJIFILM medwork]

• 04044503055828: VAL1-G7-50
• 04044503035158: FROG VAL1-F1-100