Seracult Plus Fecal Occult Blood Test Developer

GUDID 30818087013100

Seracult Plus Fecal Occult Blood Test Developer

PROPPER MANUFACTURING COMPANY, INC.

Faecal occult blood IVD, reagent

• Primary Device ID: 30818087013100
• NIH Device Record Key: 252a1564-b1b8-46c9-b527-650f57e0d675
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seracult Plus Fecal Occult Blood Test Developer
• Version Model Number: 37701500
• Company DUNS: 001483130
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Device Count: 20
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818087013106 [Unit of Use]
GS1	30818087013100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K834297

FDA Product Code

• KHE: Reagent, Occult Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-28
• Device Publish Date: 2019-05-20

Devices Manufactured by PROPPER MANUFACTURING COMPANY, INC.

• 10818087011072 - EO Chex 3/4" Indicator Tape - 48 rolls/case: 2024-08-05 EO Chex 3/4" Indicator Tape - 48 rolls/case
• 10818087011089 - EO Chex 1" Indicator Tape - 36 rolls/case: 2024-08-05 EO Chex 1" Indicator Tape - 36 rolls/case
• 10818087010815 - Seraket Tourniquets: 2023-06-26 Seraket Tourniquet - 1 EA
• 10818087010952 - Gas-Chex EO Gas 3/4" Indicator Tape: 2023-06-26 Gas-Chex EO Gas 3/4" Indicator Tape - 1 RL
• 10818087010914 - Verline Steam Autoclave Indicator Tape 1/2" x 14 YD - 24/pack: 2023-06-26 Verline Steam Autoclave Indicator Tape 1/2" x 14 YD - 24/pack
• 10818087010938 - Verline Steam Autoclave Indicator Tape 3/4" x 14 YD - 16/pack: 2023-06-26 Verline Steam Autoclave Indicator Tape 3/4" x 14 YD - 16/pack
• 10818087010945 - Verline Steam Autoclave Indicator Tape 1" x 14 YD - 12/pack: 2023-06-26 Verline Steam Autoclave Indicator Tape 1" x 14 YD - 12/pack
• 30818087010994 - Vapor Line Reusable Process Challenge Device: 2023-06-26 Vapor Line Reusable Process Challenge Device