GUDID 16938119382933

Henan Tuoren Medical Device Co.,Ltd.

Anaesthesia face mask, single-use

• Primary Device ID: 16938119382933
• NIH Device Record Key: 5039eded-5d1b-4c57-8789-2ed7f2a94871
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Inflatable type:3#
• Company DUNS: 526982680
• Company Name: Henan Tuoren Medical Device Co.,Ltd.
• Device Count: 1
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938119382929 [Primary]
GS1	16938119382933 [Package]; Contains: 06938119382929; Package: Middle Box [25 Units]; In Commercial Distribution
GS1	26938119382947 [Package]; Package: Carton [2 Units]; In Commercial Distribution

FDA Product Code

• BSJ: Mask, Gas, Anesthetic

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: 2022-11-28
• Device Publish Date: 2022-11-18

Devices Manufactured by Henan Tuoren Medical Device Co.,Ltd.

• 16938119329433 - NA: 2022-11-28
• 16938119329464 - NA: 2022-11-28
• 16938119329495 - NA: 2022-11-28 Anesthetic Mask(Bending edge model:2#)
• 16938119329525 - NA: 2022-11-28 Anesthetic Mask(Bending edge model:3#)
• 16938119329556 - NA: 2022-11-28 Anesthetic Mask(Bending edge model:4#)
• 16938119329587 - NA: 2022-11-28 Anesthetic Mask(Bending edge model:5#)
• 16938119329617 - NA: 2022-11-28 Anesthetic Mask( Detachable model:3#)
• 16938119329648 - NA: 2022-11-28 Anesthetic Mask( Detachable model:4#)