Pro-Fit 8143

GUDID 07540198001159

The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a regular size speculum with insertion guide rings, a

Prime Pacific Health Innovations Corporation

Colonic lavage kit, non-surgical

• Primary Device ID: 07540198001159
• NIH Device Record Key: 70b0e363-e1df-49df-aa53-32936de167bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Fit
• Version Model Number: Regular Kit with guide rings
• Catalog Number: 8143
• Company DUNS: 250896255
• Company Name: Prime Pacific Health Innovations Corporation
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	07540198001029 [Primary]
GS1	07540198001142 [Package]; Contains: 07540198001029; Package: Dispensing Bag [10 Units]; In Commercial Distribution
GS1	07540198001159 [Package]; Contains: 07540198001029; Package: Dispensing Bag [25 Units]; In Commercial Distribution

FDA Product Code

• FFQ: Speculum, Rectal

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: 2018-10-22
• Device Publish Date: 2016-09-23

On-Brand Devices [Pro-Fit]

• 07540198001265: The Pro-Fit Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting
• 07540198001203: The Pro-Fit Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a
• 07540198001159: The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of
• 07540198001104: The Pro-Fit Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of a
• 07540198001050: The Pro-Fit Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consisting of
• 07540198000398: The Pro-Fit Universal Speculum Pack is a package containing 20 individual Disposable, Single-use
• 07540198000381: The Pro-Fit Universal Speculum Pack is a package containing 10 individual Disposable, Single-use
• 07540198000374: The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use S
• 07540198000367: The Pro-Fit Regular Speculum Pack is a package containing 10 individual Disposable, Single-use S
• 07540198000350: The Pro-Fit Small Speculum Pack is a package containing 20 individual Disposable, Single-use Spe
• 07540198000343: The Pro-Fit Small Speculum Pack is a package containing 10 individual Disposable, Single-use Spe
• 07540198000336: The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use S
• 07540198000329: The Pro-Fit Regular Speculum Pack is a package containing 10 individual Disposable, Single-use S
• 07540198000312: The Pro-Fit Small Speculum Pack is a package containing 20 individual Disposable, Single-use Spe
• 07540198000305: The Pro-Fit Small Speculum Pack is a package containing 10 individual Disposable, Single-use Spe