ARAMARK 901138

GUDID 10830868000037

ARAMARK DRESSING 10CMX10CM (4X4")

BURNSHIELD (PTY) LTD

Synthetic polymer burn dressing, gel-coated

• Primary Device ID: 10830868000037
• NIH Device Record Key: ed4b48d0-8e40-4f40-ae26-3c1f2adb70ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARAMARK
• Version Model Number: 901138
• Catalog Number: 901138
• Company DUNS: 635842958
• Company Name: BURNSHIELD (PTY) LTD
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com
• Phone: +27114405171
• Email: sales@burnshield.com

Device Dimensions

• Weight: 40 Gram
• Width: 100 Millimeter
• Length: 100 Millimeter
• Weight: 40 Gram
• Width: 100 Millimeter
• Length: 100 Millimeter
• Weight: 40 Gram
• Width: 100 Millimeter
• Length: 100 Millimeter
• Weight: 40 Gram
• Width: 100 Millimeter
• Length: 100 Millimeter
• Weight: 40 Gram
• Width: 100 Millimeter
• Length: 100 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00830868000030 [Primary]
GS1	10830868000037 [Package]; Contains: 00830868000030; Package: BOX [125 Units]; In Commercial Distribution
GS1	20830868000034 [Package]; Package: BOX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943728

FDA Product Code

• MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-09
• Device Publish Date: 2022-06-01

Devices Manufactured by BURNSHIELD (PTY) LTD

• 16007645005781 - BURNSHIELD: 2023-11-13 BURNSHIELD ESSENTIAL BURN KIT SMALL
• 10830868000037 - ARAMARK: 2022-06-09ARAMARK DRESSING 10CMX10CM (4X4")
• 10830868000037 - ARAMARK: 2022-06-09 ARAMARK DRESSING 10CMX10CM (4X4")
• 16007645002001 - BURNSHIELD: 2021-12-22 BURNSHIELD CATER KIT
• 16007645007921 - BURNSHIELD: 2021-12-22 BURNSHIELD EMERGENCY KIT IN NYLON BAG
• 16007645000120 - BURNSHIELD: 2021-08-30 BURNSHIELD HYDROGEL BOTTLE 50ML (1.8OZ)
• 16007645001424 - BURNSHIELD: 2021-08-24 BURNSHIELD DRESSING 50MMX1M (2X40") LIMB
• 16007645005804 - BURNSHIELD: 2021-08-24 BURNSHIELD ESSENTIAL BURN KIT LARGE
• 16007645006337 - BURNSHIELD: 2021-08-24 MUNDIAL BURN KIT