VenoTrain curaflow

GUDID 04046445905797

Bauerfeind AG

Compression/pressure sock/stocking, single-use

• Primary Device ID: 04046445905797
• NIH Device Record Key: 1a0b5075-b223-48b6-96db-6ee0440d7285
• Commercial Distribution Discontinuation: 2016-10-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VenoTrain curaflow
• Version Model Number: 20000009900002
• Company DUNS: 315914853
• Company Name: Bauerfeind AG
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046445905797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111662

FDA Product Code

• DWL: Stocking, medical support (to prevent pooling of blood in legs)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-10-06

On-Brand Devices [VenoTrain curaflow]

• 04046445905803: 20000009900001
• 04046445905797: 20000009900002
• 04046445905780: 20000009900008