AccessGUDID - DEVICE: NA (00085412022956)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 2C7553
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2C7553
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412022956
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Vented Paclitaxel Set, Polyethylene Lined Tubing, Non-DEHP Pump Segment, 0.22 Micron Downstream High Pressure Filter, Injection Site, Male Luer Lock Adapter

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):	Yes
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?
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, administration, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981792	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8c72e6b0-ab30-41b1-bbc4-89180648dc70
Public Version Date: February 13, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016