DRYASOL ACP8/9/10

GUDID B467ACP452257510016

Dryasol Dry Concentrate for Bicarbonate Dialysis

DIASOL, INC.

Haemodialysis concentrate

• Primary Device ID: B467ACP452257510016
• NIH Device Record Key: b92fc6f6-ceb0-43fc-a940-52dbefb64321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRYASOL
• Version Model Number: 45225-75100
• Catalog Number: ACP8/9/10
• Company DUNS: 068434658
• Company Name: DIASOL, 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: 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

Customer Support Contacts

• Phone: 818-838-7077
• Email: Diasolinc@gmail.com
• Phone: 818-838-7077
• Email: Diasolinc@gmail.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if container is damaged and/or seal is broken. Carefully follow instructions printed on the enclosed label. No partial batch is to be prepared.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if container is damaged and/or seal is broken. Carefully follow instructions printed on the enclosed label. No partial batch is to be prepared.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B467ACP4522575100 [Primary]
HIBCC	B467ACP452257510016 [Package]; Contains: B467ACP4522575100; Package: CASE [1 Units]; In Commercial Distribution
HIBCC	B467ACP452257510020 [Package]; Contains: B467ACP4522575100; Package: CASE [1 Units]; In Commercial Distribution
HIBCC	B467ACP452257510025 [Package]; Contains: B467ACP4522575100; Package: CASE [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993212

FDA Product Code

• KPO: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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: 2017-02-27

On-Brand Devices [DRYASOL]

• B467ACP453257510016: Dryasol Dry Concentrate for Bicarbonate Dialysis
• B467ACP452257520025: Dryasol Dry Concentrate for Bicarbonate Dialysis
• B467ACP452257510016: Dryasol Dry Concentrate for Bicarbonate Dialysis
• B467ACP451257510016: Dryasol Dry Concentrate for Bicarbonate Dialysis
• B467ACP362351020025: Dryasol Dry Concentrate for Bicarbonate Dialysis
• B467ACP362251020025: Dryasol Dry Concentrate for Bicarbonate Dialysis
• B467ACP362201020025: Dryasol Dry Concentrate for Bicarbonate Dialysis
• B467ACP352251010025: Dryasol Dry Concentrate for Bicarbonate Dialysis