VenoTrain micro balance

GUDID 04046445313097

Bauerfeind AG

Compression/pressure sock/stocking, single-use

• Primary Device ID: 04046445313097
• NIH Device Record Key: 845f7d6e-e8bf-462d-a6ee-bb544ff93a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VenoTrain micro balance
• Version Model Number: 28110011100234
• 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: false
• 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	04046445313097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860826

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: 2016-09-30

On-Brand Devices [VenoTrain micro balance]

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• 04046445879081: 28160611700009
• 04046445879074: 28160611720009
• 04046445879067: 28160621100009
• 04046445879050: 28160621120009
• 04046445879043: 28160621200009
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• 04046445879012: 28160621720009
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• 04046445878961: 28160711700009
• 04046445878947: 28160721100009
• 04046445878930: 28160721120009
• 04046445878916: 28160721220009
• 04046445878909: 28160721700009
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• 04046445878886: 28180011100009
• 04046445878879: 28180011120009
• 04046445878831: 28180011720009
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• 04046445878800: 28180021200009
• 04046445878794: 28180021220009
• 04046445878787: 28180021700009
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• 04046445328411: 28180021720332
• 04046445328404: 28180021720331
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• 04046445327711: 28180021120234
• 04046445327674: 28180021120224
• 04046445327667: 28180021120223
• 04046445327643: 28180021120221
• 04046445327599: 28180021100324
• 04046445327568: 28180021100321