Hemoccult 64151

GUDID 15099590224776

Hemoccult Sensa Single Slide with Developer and Applicators

Beckman Coulter, Inc.

Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 15099590224776
• NIH Device Record Key: 269a32fe-c78a-4988-8224-de8f7f70f5af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemoccult
• Version Model Number: 64151
• Catalog Number: 64151
• Company DUNS: 008254708
• Company Name: Beckman Coulter, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590224776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880499

FDA Product Code

• KHE: Reagent, Occult Blood

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: 2016-09-23

On-Brand Devices [Hemoccult]

• 15099590390341: Hemoccult Sensa Single Slides without Developer (box of 100)
• 15099590231972: Hemoccult Single Slides (BX/100)
• 15099590231965: Hemoccult Single Slides - CS/1000
• 15099590227302: Hemoccult ICT Immunochemical Fecal Occult Blood Test
• 15099590226879: Hemoccult Tape (2 Kits/BX)
• 15099590226794: Hemoccult Sensa Dev (20 15 mL/CS)
• 15099590226770: Hemoccult II Sensa Dispensapak Plus
• 15099590224776: Hemoccult Sensa Single Slide with Developer and Applicators
• 15099590224707: Hemoccult Sensa Sng Sld-CS/1000
• 15099590221799: Hemoccult II Dispensapak
• 15099590221782: Hemoccult II Dispensapak Plus
• 15099590221751: Hemoccult II Slides
• 15099590221669: Hemoccult ICT - 40 Patient Screening Kit
• 15099590221461: HEMOCCULT ICT COLLECTION CARDS
• 15099590221157: Hemoccult ICT Immunochemical Fecal Occult Blood Test Controls
• 15099590220990: Hemoccult Dev (20 15 mL Btl/Case)
• 15099590180072: Hemoccult ICT 2 Day- 50 Patient Screening Kit