Reprocessed Venaflow Calf Cuff, Large, 1 Pair

GUDID B39030121

SURETEK MEDICAL

Single-chamber venous compression system garment, reprocessed

• Primary Device ID: B39030121
• NIH Device Record Key: e5935cb1-9f1b-48ea-adf0-e0942784a71a
• Commercial Distribution Discontinuation: 2017-08-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Reprocessed Venaflow Calf Cuff, Large, 1 Pair
• Version Model Number: 3012
• Company DUNS: 785616934
• Company Name: SURETEK MEDICAL
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B39030121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052691

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-09
• Device Publish Date: 2016-09-12

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