QUAKE 1297

GUDID 10383480000065

QUAKE VIBRATORY PEP DEVICE

THAYER MEDICAL CORPORATION

Mechanical positive pressure airway secretion-clearing device

• Primary Device ID: 10383480000065
• NIH Device Record Key: 5834dc95-4c27-4d63-a6aa-e417024a29e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUAKE
• Version Model Number: 1297
• Catalog Number: 1297
• Company DUNS: 626238844
• Company Name: THAYER MEDICAL CORPORATION
• Device Count: 1
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM
• Phone: 1-800-250-3330
• Email: INFO@THAYERMEDICAL.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383480000068 [Primary]
GS1	10383480000065 [Package]; Contains: 00383480000068; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974849

FDA Product Code

• BYI: Percussor, Powered-Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

Devices Manufactured by THAYER MEDICAL CORPORATION

• 00383480000594 - LiteAire BASIC: 2024-09-19 LITEAIRE BASIC: DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER. CATALOG NUMBER 1803 IS 1 INDIVIDUAL LITEAIRE BASIC UNIT. AVAILABLE
• 10383480000003 - LITEAIRE: 2023-05-17 LITEAIRE ENHANCED - DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER (ENHANCED): CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT.
• 40383480000493 - LITEAIRE: 2019-09-16 DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER: CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT. CATALOG NUMBER 1304 IS 1 DISPEN
• 00383480000013 - VALVED TEE ADAPTER: 2019-01-23 VALVED TEE ADAPTER WITH 22MM O.D. X 22MM O.D. CONNECTIONS
• 10383480000027 - VALVED TEE ADAPTER: 2019-01-23 VALVED TEE ADAPTER WITH 10MM O.D. X 10MM O.D. CONNECTIONS
• 10383480000034 - VALVED TEE ADAPTER: 2019-01-23 VALVED TEE ADAPTER WITH 22MM O.D. X 22MM I.D. CONNECTIONS
• 10383480000041 - VALVED TEE ADAPTER: 2019-01-23 VALVED TEE ADAPTER WITH 15MM O.D. X 15MM I.D. CONNECTIONS
• 10383480000072 - MEDLINE VALVED TEE ADAPTER: 2019-01-23 MEDLINE VALVED TEE ADAPTER WITH 22MM O.D. X 22MM O.D