Compreflex Pulse Calf MD R Beige 3612-UC-BKR

GUDID 00745129331474

Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device.

SIGVARIS INC

General-purpose medical foam padding, single-use

• Primary Device ID: 00745129331474
• NIH Device Record Key: d0e1a216-b1f3-4603-9d94-4cf370e08f1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compreflex Pulse Calf MD R Beige
• Version Model Number: 21750
• Catalog Number: 3612-UC-BKR
• Company DUNS: 189738719
• Company Name: SIGVARIS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com
• Phone: +1(800)322-7744
• Email: sigvariscares@sigvaris.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00745129331474 [Primary]

FDA Product Code

• MDR: Binder, Medical, Therapeutic

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: 2025-07-11
• Device Publish Date: 2025-07-03

Devices Manufactured by SIGVARIS INC

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• 00745129317829 - Coolflex Arm Small Long Right (BULK): 2025-07-11 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129318055 - Coolflex Boot SM Long LT Black (BULK): 2025-07-11 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331368 - Compreflex Pulse Calf SM T Black: 2025-07-11 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331375 - Compreflex Pulse Calf MD R Black: 2025-07-11 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331382 - Compreflex Pulse Calf MD T Black: 2025-07-11 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331399 - Compreflex Pulse Calf LG R Black: 2025-07-11 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff
• 00745129331405 - Compreflex Pulse Calf LG T Black: 2025-07-11 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff