AMD-RITMED PREMIUM 9970D

GUDID 20686864059039

AMD-RITMED PREMIUM NITRILE EXAMINATION GLOVES Blue Powder-Free Large

AMD Medicom Inc

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 20686864059039
• NIH Device Record Key: b61f072d-0cef-47c7-a708-ce6f7a23bec3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMD-RITMED PREMIUM
• Version Model Number: 9970D
• Catalog Number: 9970D
• Company DUNS: 256880576
• Company Name: AMD Medicom Inc
• Device Count: 200
• 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: 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: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca
• Phone: +1(514)636-6262
• Email: mdasilva@medicom.ca

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• 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 - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)
• Special Storage Condition, Specify: Between 0 and 0 *Cool dry place - Avoid excessive heat (40 °C, 104 °F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00686864059370 [Unit of Use]
GS1	10686864059032 [Primary]
GS1	20686864059039 [Package]; Contains: 10686864059032; Package: Outer Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182383

FDA Product Code

• LZA: Polymer patient examination glove
• LZC: Patient Examination Glove, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-04-06
• Device Publish Date: 2019-01-16

On-Brand Devices [AMD-RITMED PREMIUM]

• 20686864049627: AMD-RITMED THUMBLOOP ISOLATION GOWN 3X-Large
• 20686864059039: AMD-RITMED PREMIUM NITRILE EXAMINATION GLOVES Blue Powder-Free Large
• 20686864052337: AMD-RITMED PREMIUM THUMBLOOP ISOLATION GOWN Regular