Respire Pink AT Series,Splint

GUDID 06972677871891

Modern Dental Laboratory (DG) Co., Ltd.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 06972677871891
• NIH Device Record Key: 00705bfd-f3dd-4b94-b8b8-80b7935df26a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respire Pink AT Series,Splint
• Version Model Number: 188
• Company DUNS: 551746187
• Company Name: Modern Dental Laboratory (DG) Co., Ltd.
• Device Count: 2
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	06972677871884 [Primary]
GS1	06972677871891 [Unit of Use]

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

[06972677871891]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by Modern Dental Laboratory (DG) Co., Ltd.

• 06972677870214 - Trioclear System: 2023-09-12
• 06972677870221 - Trioclear System: 2023-09-12
• 06972677870238 - Trioclear System: 2023-09-12
• 06972677870207 - Orthodontic Appliance: 2023-08-16
• 06972677870191 - Respire Pink AT Series: 2022-09-27
• 06972677871877 - Respire Pink AT Series,Retainer: 2022-09-27
• 06972677871891 - Respire Pink AT Series,Splint: 2022-09-27
• 06972677871891 - Respire Pink AT Series,Splint: 2022-09-27
• 06972677870153 - Blue Series: 2022-09-05