OTI

GUDID 06978333140035

face mask Headstrap

Xiamen Oti Electronic Industry Co., Ltd.

Anaesthesia mask strap, reusable

• Primary Device ID: 06978333140035
• NIH Device Record Key: 9ccab9e7-b9e9-43d3-b5c8-5535bdfdcd1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTI
• Version Model Number: 8150
• Company DUNS: 528147084
• Company Name: Xiamen Oti Electronic Industry Co., Ltd.
• Device Count: 50
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn
• Phone: 18950122603
• Email: anita@otixm.cn

Device Identifiers

Device Issuing Agency	Device ID
GS1	06978333140028 [Primary]
GS1	06978333140035 [Unit of Use]

FDA Product Code

• BTK: Strap, Head, Gas Mask

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: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [OTI]

• 06978333140035: face mask Headstrap
• 06978333140004: face mask Headstrap