RITMED VERSAGOWN A69952

GUDID 20686864051873

RITMED VERSAGOWN FLEXNECK IMPERVIOUS Level 2 Thumbloop Yellow X-Large

AMD Medicom Inc

Isolation gown, single-use

• Primary Device ID: 20686864051873
• NIH Device Record Key: 18a5e0c3-036c-4796-a85e-272faf733d18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RITMED VERSAGOWN
• Version Model Number: A69952
• Catalog Number: A69952
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 10
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca
• Phone: +1(514)636-6262
• Email: mkansou@medicom.ca

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 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 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 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 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864051879 [Unit of Use]
GS1	10686864051876 [Primary]
GS1	20686864051873 [Package]; Contains: 10686864051876; Package: Outer Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190306

FDA Product Code

• FYC: Gown, Isolation, Surgical
• OEA: Non-surgical isolation gown

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-08-28
• Device Publish Date: 2019-01-17

Devices Manufactured by AMD Medicom Inc

• 20686864061278 - RITMED: 2025-01-14 Ritmed Precision - Isolation gown with over-the-head design - AAMI Level 2 - Yellow - Large
• 20686864061285 - RITMED: 2025-01-14 Ritmed Precision - Isolation gown with over-the-head design - AAMI Level 2 - Yellow, X-Large
• 20686864060905 - RITMED: 2024-12-10 Ritmed Forefront Open-Back Proctective Gown Level 4 - BLUE - Size: Universal
• 00686864061298 - Medicom AssureTouch Noir: 2024-12-03 Medicom AssureTouch Noir Nitrile S Sample Pack
• 00686864061304 - Medicom AssureTouch Noir: 2024-12-03 Medicom AssureTouch Noir Nitrile M Sample Pack
• 00686864061311 - Medicom AssureTouch Noir: 2024-12-03 Medicom AssureTouch Noir Nitrile L Sample Pack
• 00686864060840 - SafeMask: 2024-11-20 Artisan E/L blue L2
• 00686864060857 - SafeMask: 2024-11-20 Artisan E/L blue L3