AccessGUDID - DEVICE: DUPLOCATH (00085412314112)

GUDID

Device Identifier (DI) Information

Brand Name: DUPLOCATH
Version or Model: 921021
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 921021
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412314112
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: 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":	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?
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 [?]
K973510	000

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 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 180 Centimeter

Device Record Status

Public Device Record Key: 7fc89843-d487-4c12-8eeb-6d13c124a6db
Public Version Date: July 21, 2023
Public Version Number: 5
DI Record Publish Date: October 12, 2016