Hays Innovations H1000SE

GUDID 20869566000237

Hays Ultrasound kit

HAYS, INC.

Medical equipment drape, single-use

• Primary Device ID: 20869566000237
• NIH Device Record Key: 497f4ffd-658a-4faf-b376-b57a465e1822
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hays Innovations
• Version Model Number: H1000E
• Catalog Number: H1000SE
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869566000233 [Primary]
GS1	10869566000230 [Package]; Contains: 00869566000233; Package: Box [10 Units]; In Commercial Distribution
GS1	20869566000237 [Package]; Contains: 10869566000230; Package: Case [6 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2020-03-25
• Device Publish Date: 2016-09-09

On-Brand Devices [Hays Innovations]

• 00869566000264: Hays Ultrasound kit
• 20869566000237: Hays Ultrasound kit
• 00869566000202: Regular PE Film Probe Cover 6" X 48"