Hays Inc. HS1500AS

GUDID 00860003700839

Hays Innovations Anchor Sound Device

HAYS, INC.

Medical equipment drape, single-use

• Primary Device ID: 00860003700839
• NIH Device Record Key: 5f3ce94f-fe2d-4f33-b4f5-e8aae9a83b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hays Inc.
• Version Model Number: HS1500AS
• Catalog Number: HS1500AS
• Company DUNS: 079906040
• Company Name: HAYS, INC.
• 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003700822 [Primary]
GS1	00860003700839 [Package]; Contains: 00860003700822; Package: inner case [20 Units]; In Commercial Distribution
GS1	00860003700846 [Package]; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-25
• Device Publish Date: 2020-06-02

Devices Manufactured by HAYS, INC.

• 00860003700839 - Hays Inc.: 2024-07-25Hays Innovations Anchor Sound Device
• 00860003700839 - Hays Inc.: 2024-07-25 Hays Innovations Anchor Sound Device
• 00860003700853 - Hays Inc: 2021-12-24 Hays Innovations Sterile Short US Probe Cover Kit
• 00860003700860 - Hays Inc: 2021-02-12 Hays Innovations Sterile Short US Probe Cover Kit
• 00860003700808 - Hays Inc: 2020-04-07 Hays Innovations Sterile Ultrasound Probe Cover Kit
• 20869566000237 - Hays Innovations: 2020-03-25 Hays Ultrasound kit
• 00869566000202 - Hays Innovations: 2018-03-29 Regular PE Film Probe Cover 6" X 48"
• 00869566000264 - Hays Innovations: 2018-03-29 Hays Ultrasound kit