OCEAN PACIFIC INTUITION OPXL-IN

GUDID 20686864042383

Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Lilac - X-Large

AMD Medicom Inc

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

• Primary Device ID: 20686864042383
• NIH Device Record Key: af251636-085c-46e4-8818-de5a1842a32f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCEAN PACIFIC INTUITION
• Version Model Number: OPXL-IN
• Catalog Number: OPXL-IN
• 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: true
• 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

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

Operating and Storage Conditions

• 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	00686864042389 [Unit of Use]
GS1	10686864042386 [Primary]
GS1	20686864042383 [Package]; Contains: 10686864042386; Package: Outer case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162095

FDA Product Code

• LZA: Polymer Patient Examination Glove

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: 2023-06-02
• Device Publish Date: 2023-05-25

On-Brand Devices [OCEAN PACIFIC INTUITION]

• 00686864059646: Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fi
• 20686864042529: Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fi
• 20686864042383: Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fi
• 20686864042253: Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fi
• 20686864042116: Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fi
• 20686864041973: Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fi