AccessGUDID - DEVICE: DUPLOCATH (00085412600024)

GUDID

Device Identifier (DI) Information

Brand Name: DUPLOCATH
Version or Model: 1506165
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1506165
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412600024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Catheter for the simultaneous application of Baxter's two-component fibrin sealant in areas of the operation site where access is difficult. The Application of Baxter's two-component fibrin sealant can be carried out via a double syringe system and the two-lumen Duplocath application catheter

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":	Yes
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?
44830	Open-surgery adhesive/sealant applicator, dual-channel	A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstruction). The device, also known as a surgical sealant dispenser (SSD), is typically made of flexible metal or synthetic material, and has a connector at one end to attach a compatible dispensing device (e.g., a dual-component syringe). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK170033	0

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
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 25 Centimeter

Device Record Status

Public Device Record Key: 96b43f6d-247a-495b-91d0-baf3691f2bc9
Public Version Date: July 10, 2023
Public Version Number: 5
DI Record Publish Date: September 28, 2018