RITMED ASSUREWEAR A69978

GUDID 00686864057826

RITMED ASSUREWEAR Isolation Gown Level 2 Over-the-head, Yellow, 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

• Primary Device ID: 00686864057826
• NIH Device Record Key: cbb93261-be23-478a-bbbc-deec955728bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RITMED ASSUREWEAR
• Version Model Number: A69978
• Catalog Number: A69978
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864057826 [Unit of Use]
GS1	10686864057823 [Primary]
GS1	20686864057820 [Package]; Contains: 10686864057823; Package: OUTER CASE [10 Units]; In Commercial Distribution

FDA Product Code

• OEA: Non-surgical isolation gown

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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [RITMED ASSUREWEAR]

• 00686864056997: RITMED ASSUREWEAR IMPERVIOUS Level 2 Neck ties & Knit cuffs - Yellow - Large
• 00686864057826: RITMED ASSUREWEAR Isolation Gown Level 2 Over-the-head, Yellow, X-Large
• 20686864060677: Ritmed AssureWear - Isolation Gown - Level 2 - Over-the-head - Yellow - X-Large
• 20686864060660: Ritmed AssureWear - Isolation Gown - Level 2 - Over-the-head - Yellow - Large
• 20686864057813: Ritmed AssureWear - Isolation Gown - Level 2 - Over-the-head - Yellow - Large