AVANOS 69100

GUDID 00350770928081

Bite Block

Avanos Medical, Inc.

Endoscopic bite block, basic, single-use

• Primary Device ID: 00350770928081
• NIH Device Record Key: 48055a8e-987d-45de-a33a-b82fa64ffbfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVANOS
• Version Model Number: 92808
• Catalog Number: 69100
• Company DUNS: 079375431
• Company Name: Avanos Medical, Inc.
• Device Count: 24
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM
• Phone: +1(844)428-2667
• Email: PIQ@AVANOS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00350770928081 [Primary]
GS1	10350770928088 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830781

FDA Product Code

• FOG: HOOD, OXYGEN, INFANT

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: 2020-02-13
• Device Publish Date: 2020-02-05

On-Brand Devices [AVANOS]

• 00350770471136: Self-Righting Syringe Cap
• 00350770471129: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 1mL
• 00350770471112: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 3mL
• 00350770471105: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 5mL
• 00350770471099: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 10mL
• 00350770471068: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 20mL
• 00350770471051: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 60mL
• 10350770470747: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 1mL
• 10350770470730: Enteral Low Dose Tip Syringe with ENFit® Compatible Connector, 3mL
• 10350770470716: Enteral Syringe with ENFit® Connector, 10mL
• 10350770470709: Enteral Syringe with ENFit® Connector, 20mL
• 10350770470693: Enteral Syringe with ENFit® Connector, 60mL
• 10350770928118: Endoscope Cleaning Device
• 10350770928101: * Foreign Body Retrieval Hood Protector
• 10350770926527: Dual-Ended Utility Cleaning Brush
• 10350770926510: * Dual-Ended Cleaning Brush
• 10350770926503: * Dual-Ended Cleaning Brush
• 10350770926497: * Dual-Ended Cleaning Brush
• 10350770926480: * Dual-Ended Cleaning Brush
• 10350770926473: * Dual-Ended Cleaning Brush
• 10350770926466: * Dual-Ended Cleaning Brush
• 10350770926459: * Single-Ended Cleaning Brush
• 10350770926442: * Single-Ended Cleaning Brush
• 10350770926435: * Single-Ended Cleaning Brush
• 10350770456093: Enteral Device Declogging System
• 10350770454600: CLOG ZAPPER* with Applicator, Enteral Feeding Tube Declogging System
• 00193493996346: COOLIEF* TransDiscal* Cooled Radiofrequency Kit
• 10193493980076: COOLIEF* SINERGY* Epsilon* Ruler
• 00193493469420: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469390: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469383: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469369: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469352: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469345: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469338: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469321: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493469291: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493442546: COOLIEF* TRANSDISCAL* Cooled Radiofrequency Probe
• 00193493442010: COOLIEF* Cooled Radiofrequency Probe
• 00193493441945: COOLIEF* Cooled Radiofrequency Probe
• 00193493441938: COOLIEF* Cooled Radiofrequency Probe
• 00193493440771: COOLIEF* Cooled Radiofrequency Probe
• 00193493406081: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493405909: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493405893: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493405886: COOLIEF* Multi-Cooled Radiofrequency Kit
• 00193493096930: COOLIEF* Cooled Radiofrequency Sterile Tube Kit
• 10350770984602: MIC-KEY* Over-the-Wire Stoma Measuring Device
• 00350770949543: MIC* PEG Replacement Feeding Adapter, 24 Fr
• 00350770949536: MIC* PEG Replacement Feeding Adapter, 20 Fr