AccessGUDID - DEVICE: Port Access Kit (00801741096402)

GUDID

Device Identifier (DI) Information

Brand Name: Port Access Kit
Version or Model: PA-0029YNG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA-0029YNG
Company Name: Bard Access Systems, Inc.

Primary DI Number: 00801741096402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044611812 *Terms of Use

Device Description: SafeStep PAK 22G x 3/4 Y-site with GuardIVa

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:	Yes
Combination Product:	Yes
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?
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. 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 [?]
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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 3/4 Inch
Needle Gauge: 22 Gauge

Device Record Status

Public Device Record Key: e617f49b-1a1a-4bf3-a2a3-b0b40844097e
Public Version Date: October 23, 2019
Public Version Number: 3
DI Record Publish Date: February 25, 2016