RITMED ASSURE WEAR VERSAGOWN A69956

GUDID 20686864041140

RITMED ASSUREWEAR VERSAGOWN FLEXNECK IMPERVIOUS - Over the head,Thumbloop, Blue X-Large

AMD Medicom Inc

Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use Isolation gown, single-use

• Primary Device ID: 20686864041140
• NIH Device Record Key: 17161f1c-f3b9-493f-9b29-16789ce86adf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RITMED ASSURE WEAR VERSAGOWN
• Version Model Number: A69956
• Catalog Number: A69956
• 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: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com
• Phone: +1(514)636-6262
• Email: dabecassis@amdritmed.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864041146 [Unit of Use]
GS1	10686864041143 [Primary]
GS1	20686864041140 [Package]; Contains: 10686864041143; 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: 2022-06-21
• Device Publish Date: 2019-01-17

On-Brand Devices [RITMED ASSURE WEAR VERSAGOWN ]

• 10686864056215: RITMED ASSURE WEAR VERSAGOWN FLEXNECK SMS Thumbloop Yellow Large
• 20686864056434: RITMED ASSURE WEAR VERSAGOWN FLEXNECK ISOLATION GOWN UNI
• 20686864056427: RITMED ASSURE WEAR VERSAGOWN FLEXNECK IMPERVIOUS OTH Blue UNI
• 20686864041140: RITMED ASSUREWEAR VERSAGOWN FLEXNECK IMPERVIOUS - Over the head,Thumbloop, Blue X-Large