CareGuard® 1198-60

GUDID M7831198601

Bite Block With White Soft Strap

DIVERSATEK HEALTHCARE, INC.

Endoscopic bite block, basic, single-use

• Primary Device ID: M7831198601
• NIH Device Record Key: aab039ce-0c59-45d3-b564-0bd351b13a73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareGuard®
• Version Model Number: 1198-60
• Catalog Number: 1198-60
• Company DUNS: 030650113
• Company Name: DIVERSATEK HEALTHCARE, INC.
• 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: false
• Expiration Date: true
• 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: 800-558-6408
• Email: sales@diversatekhc.com

Device Dimensions

• Lumen/Inner Diameter: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7831198600 [Primary]
HIBCC	M7831198601 [Package]; Contains: M7831198600; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• MNK: Endoscopic Bite Block

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-10
• Device Publish Date: 2016-09-17

On-Brand Devices [CareGuard®]

• M783119860XL1: Bite Block With White Soft Strap
• M7831198601: Bite Block With White Soft Strap
• M7831198481: Bite Block With White Soft Strap
• M783119760XL1: Bite Block
• M7831197600: Bite Block
• M7831197481: Bite Block
• M783119660XL1: Bite Block with Blue Latex Free Strap
• M7831196600: Bite Block with Blue Latex Free Strap
• M7831196481: 1196-48