GUDID 16938119331115

Henan Tuoren Medical Device Co.,Ltd.

Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use Heat/moisture exchanger, single-use

• Primary Device ID: 16938119331115
• NIH Device Record Key: 438edba6-3812-480d-846a-20cdd5932690
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Tracheotomy
• 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	06938119331101 [Primary]
GS1	16938119331115 [Package]; Contains: 06938119331101; Package: Middle Box [200 Units]; In Commercial Distribution
GS1	26938119331129 [Package]; Package: Carton [2 Units]; In Commercial Distribution

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

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#)