Adept Adhesion Reduction Solution 0600041

GUDID 00085412086217

Adept (4% icodextrin solution) is a single use, sterile, clear, colorless to pale yellow fluid for intraperitoneal administration, containing icodextrin at a concentration of 4% w/v in an electrolyte solution, presented in a flexible polyvinylchloride bag. Adept is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.

BAXTER INTERNATIONAL INC.

Surgical anti-adhesion dressing, implantable, bioabsorbable

• Primary Device ID: 00085412086217
• NIH Device Record Key: bc701843-5cd4-49b0-9bd5-da7889c7e2d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adept Adhesion Reduction Solution
• Version Model Number: 0600041
• Catalog Number: 0600041
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL 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: false
• 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: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Dimensions

• Total Volume: 1500 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412086217 [Primary]
GS1	50085412086212 [Package]; Package: CASE [5 Units]

FDA Product Code

• MCN: Barrier, Absorable, Adhesion

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-10
• Device Publish Date: 2017-03-23

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