AccessGUDID - DEVICE: Adept Adhesion Reduction Solution (00085412086217)

GUDID

Device Identifier (DI) Information

Brand Name: Adept Adhesion Reduction Solution
Version or Model: 0600041
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0600041
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412086217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MCN	Barrier, Absorable, Adhesion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not refrigerate or freeze (do not store below 4°C)
Storage Environment Temperature: between 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1500 Milliliter

Device Record Status

Public Device Record Key: bc701843-5cd4-49b0-9bd5-da7889c7e2d1
Public Version Date: December 20, 2022
Public Version Number: 5
DI Record Publish Date: March 23, 2017