AccessGUDID - DEVICE: TISSEEL/ARTISS SPRAY SET (05413765583438)

GUDID

Device Identifier (DI) Information

Brand Name: TISSEEL/ARTISS SPRAY SET
Version or Model: 1504266
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1504266
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 05413765583438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and a clip to be attached to the double syringe system plunger for gas activation.

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 [?]
K050495	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 36 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: efd3eadf-2f00-4e77-9a10-db68e7968b77
Public Version Date: July 21, 2023
Public Version Number: 4
DI Record Publish Date: September 30, 2020