Adept Adhesion Reduction Solution

Basic Information

• Brand Name: Adept Adhesion Reduction Solution
• Primary DI: 00085412086217
• Version / Model: 0600041
• Catalog Number: 0600041
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-23
• Public Version: 5
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: bc701843-5cd4-49b0-9bd5-da7889c7e2d1

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCN	Barrier, Absorable, Adhesion	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
34212	Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated	A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00085412086217	GS1
Package	50085412086212	GS1	CASE	5

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	1500	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not refrigerate or freeze (do not store below 4°C)
• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius