HemaPrompt

GUDID 00693501000220

HemaPrompt fecal occult blood test

AERSCHER, INC

Faecal occult blood IVD, reagent

• Primary Device ID: 00693501000220
• NIH Device Record Key: 98f7ef55-a60c-490f-8da1-797d9f3a55ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemaPrompt
• Version Model Number: HP
• Company DUNS: 926911454
• Company Name: AERSCHER, INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 410-778-2957
• Email: wanda@hemprompt.com
• Phone: 410-778-2957
• Email: wanda@hemprompt.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00069350100022 [Unit of Use]
GS1	00693501000220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905782

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: 2016-08-22

Devices Manufactured by AERSCHER, INC

• 00693501000152 - HemaPrompt FG: 2018-07-06 HemaPrompt FG Fecal and Gastric Test Kit
• 00693501000220 - HemaPrompt: 2018-07-06HemaPrompt fecal occult blood test
• 00693501000220 - HemaPrompt: 2018-07-06 HemaPrompt fecal occult blood test