Barrier® EasyWarm®

GUDID 07333350154653

EasyWarm, ACTIVE SELF-WARMING BLANKET, 92x152 cm

Mölnlycke Health Care AB

Activated-medium surgical warming blanket

• Primary Device ID: 07333350154653
• NIH Device Record Key: 607cf11a-5d2f-4e97-817b-4032a2f5b521
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barrier® EasyWarm®
• Version Model Number: 629905
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false

Customer Support Contacts

• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com
• Phone: +46737733775
• Email: pedro.lopes@molnlycke.com

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
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07333350154653 [Package]; Contains: 07333350371685; Package: CASE [10 Units]; In Commercial Distribution
GS1	07333350371685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232508

FDA Product Code

• DWJ: System, thermal regulating

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: 2024-11-11
• Device Publish Date: 2024-11-01

Devices Manufactured by Mölnlycke Health Care AB

• 07333350154653 - Barrier® EasyWarm®: 2024-11-11EasyWarm, ACTIVE SELF-WARMING BLANKET, 92x152 cm
• 07333350154653 - Barrier® EasyWarm®: 2024-11-11 EasyWarm, ACTIVE SELF-WARMING BLANKET, 92x152 cm
• 07333350623876 - Mölnlycke®: 2024-11-08 MEDICAL FACE MASK
• 07333350882938 - Mölnlycke®: 2024-11-08 CAP PHILIP
• 07333350978198 - Mölnlycke®: 2024-11-08 CAP FLORY
• 07333350794071 - Mölnlycke®: 2024-11-08 MEDICAL FACE MASK
• 07333350550288 - Mölnlycke®: 2024-11-08 MEDICAL FACE MASK
• 07333350620141 - Mölnlycke®: 2024-11-08 MEDICAL FACE MASK
• 07333350648312 - Avance®: 2024-11-08 Avance Solo Carrier Case